A Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled HH-120 Aerosol in Healthy Volunteers

NCT05116865 | Completed Phase 1

• 1 other identifier: HH120-101
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, randomized, double-blinded, placebo controlled, dose escalation study of HH-120 in healthy adult volunteers. HH-120 is a novel inhalable biologic being developed for COVID-19 treatment. The study aims to evaluate the safety, tolerability and pharmacokinetic profile of HH-120 administered by aerosol inhalation after single and multiple ascending doses.

Conditions

COVID-19 Respiratory Infection

Outcome Measures

Primary Outcomes (11)

• Number of participants with treatment emergent adverse events (TEAEs)

  An Adverse Event (AE) is any event, side-effect or any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE that started on or after the first study treatment or that worsened after the first study treatment will be regarded as TEAEs.

  Day 1- Day 15 (SAD) or Day 22 (MAD)

• Severity of treatment emergent adverse events (TEAEs)as assessed by CTCAE v5.0

  An Adverse Event (AE) is any event, side-effect or any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE that started on or after the first study treatment or that worsened after the first study treatment will be regarded as TEAEs.

  Day 1- Day 15 (SAD) or Day 22 (MAD)

• Duration of treatment emergent adverse events (TEAEs)

  An Adverse Event (AE) is any event, side-effect or any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE that started on or after the first study treatment or that worsened after the first study treatment will be regarded as TEAEs.

  Day 1- Day 15 (SAD) or Day 22 (MAD)

• Number of participants with serious adverse events (SAEs)

  A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of IP (active or placebo) that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect

  Day 1- Day 15 (SAD) or Day 22 (MAD)

• Severity of serious adverse events (SAEs) as assessed by CTCAE v5.0

  A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of IP (active or placebo) that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect

  Day 1- Day 15 (SAD) or Day 22 (MAD)

• Duration of serious adverse events (SAEs)

  A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of IP (active or placebo) that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect

  Day 1- Day 15 (SAD) or Day 22 (MAD)

• Number of participants with abnormal clinically significant physical examination findings

  Complete and symptom directed physical examination will be performed

  Day 1- Day 15 (SAD) or Day 22 (MAD)

• Number of participants with abnormal clinically significant electrocardiogram (ECG)

  Single resting 12- lead ECGs will be collected

  Day 1- Day 15 (SAD) or Day 22 (MAD)

• Number of participants with clinically significant change in vital signs from baseline

  Vital signs include heart rate, blood pressure, respiratory rate and tympanic temperature

  Day 1- Day 15 (SAD) or Day 22 (MAD)

• Changes in the spirometry score from Baseline

  Measured by Forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) after dosing

  Day 1- Day 15 (SAD) or Day 22 (MAD)

• Number of participants with abnormal clinically significant clinical laboratory parameters

  Clinical laboratory test include hematology, coagulation, biochemistry and urinalysis

  Day 1- Day 15 (SAD) or Day 22 (MAD)

Secondary Outcomes (13)

• Cmax in SAD and MAD

  Day 1- Day 15 (SAD) or Day 22 (MAD)

• Tmax in SAD and MAD

  Day 1- Day 15 (SAD) or Day 22 (MAD)

• t1/2 in SAD and MAD part

  Day 1- Day 15 (SAD) or Day 22 (MAD)

• AUC0-last

  Day 1- Day 15 (SAD) or Day 22 (MAD)

• AUC0-inf

  Day 1- Day 15 (SAD) or Day 22 (MAD)

Study Arms (6)

Single Ascending Dose Cohort A1

EXPERIMENTAL

Subjects will receive a single dose of either dose level 1 of HH-120 or placebo

Biological: HH-120 Dose 1; Drug: Placebo

Single Ascending Dose Cohort A2

EXPERIMENTAL

Subjects will receive a single dose of either dose level 2 of HH-120 or placebo

Biological: HH-120 Dose 2; Drug: Placebo

Single Ascending Dose Cohort A3

EXPERIMENTAL

Subjects will receive a single dose of either dose level 3 of HH-120 or placebo

Biological: HH-120 Dose 3; Drug: Placebo

Multiple Ascending Doses Cohort B1

EXPERIMENTAL

Subjects will receive multiple doses of either Dose level 1of HH-120 or placebo

Biological: HH-120 Dose 1; Drug: Placebo

Multiple Ascending Doses Cohort B2

EXPERIMENTAL

Subjects will receive multiple doses of either Dose level 2 of HH-120 or placebo

Biological: HH-120 Dose 2; Drug: Placebo

Multiple Ascending Doses Cohort B3

EXPERIMENTAL

Subjects will receive multiple doses of either Dose level 3 of HH-120 or placebo

Biological: HH-120 Dose 3; Drug: Placebo

Interventions

HH-120 Dose 1 BIOLOGICAL

Dose level 1 of HH-120

Also known as: HH-120

Multiple Ascending Doses Cohort B1; Single Ascending Dose Cohort A1

HH-120 Dose 2 BIOLOGICAL

Dose level 2 of HH-120

Also known as: HH-120

Multiple Ascending Doses Cohort B2; Single Ascending Dose Cohort A2

HH-120 Dose 3 BIOLOGICAL

Dose level 3 of HH-120

Also known as: HH-120

Multiple Ascending Doses Cohort B3; Single Ascending Dose Cohort A3

Placebo DRUG

Placebo to match

Multiple Ascending Doses Cohort B1; Multiple Ascending Doses Cohort B2; Multiple Ascending Doses Cohort B3; Single Ascending Dose Cohort A1; Single Ascending Dose Cohort A2; Single Ascending Dose Cohort A3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female volunteers aged 18 to 65 years (both inclusive)
• Participants must have a body mass index between ≥ 18.0 and ≤ 32 .0 kg/m2 and a bodyweight of at least 45 kg at Screening.
• Participants must be a non-smoker and must not have used any tobacco products within 90 days prior to Screening.
• Participants must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at screening and/or before administration of the initial dose of IP.
• Participants must have clinical laboratory values within normal range.
• Females must be non-pregnant and non-lactating, and must use an acceptable, highly effective double contraception from Screening until study completion, including the follow-up period.
• Males must not donate sperm for at least 90 days after the last dose of IP.
• Participants must have the ability and willingness to attend the necessary visits to the CRU.

You may not qualify if:

• Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.
• Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the PI's (or delegate's) opinion, could adversely affect the safety of the participant or that might interfere with the conduct of the study.
• Presence of any underlying physical or psychological medical condition
• Pre-existing severe obstructive disease of the respiratory system such as chronic obstructive pulmonary disease or asthma , including resolved childhood asthma, which may impact inhalation as judged by the PI, delegate, or Sponsor.
• History or evidence o f any anatomical airway defect, which in the opinion of the PI, may impact inhalation.
• Abnormal spirometry findings at Screening that are considered by the PI to be clinically significant, including FEV1 \< 80% or FVC \< 80%.
• Blood donation of \> 500 mL or significant blood loss within 60 days prior to the first IP administration or plasma donation within 7 days prior to IP administration.
• Systemic or respiratory infection within 2 weeks before the Screening visit or fever (tympanic temperature \> 37.5°C) or symptomatic viral or bacterial infection at time of Screening.
• Current infection with SARS-CoV-2, infection within the 2 weeks prior to Screening, or a history of SARS-CoV-2 infection plus symptoms of post-COVID syndrome.
• History of anaphylaxis or other significant allergy in the opinion of the PI or known allergy or hypersensitivity to any of the components of the IP.
• History of malignancy, except for non-melanoma skin cancer, excised more than 2 years ago and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening.
• A personal history of unexplained blackouts or fainting or known risk factors for Torsade de Pointes (eg, hypokalemia, heart failure).
• Abnormal 12-lead ECG findings at Screening that are considered by the PI to be clinically significant, including arrhythmias or marked QT interval abnormalities (QTcF \< 300 msec or ≥ 450 msec at Screening).
• Confirmed (eg, 2 consecutive triplicate measurements) average systolic blood pressure (SBP) \> 140 or \< 90 mmHg, and diastolic blood pressure (DBP) \> 90 or \< 45 mmHg at Screening.
• Confirmed (eg, 2 consecutive triplicate measurements) average resting HR \> 100 or \< 45 beats per minute at Screening.

Sponsors & Collaborators

• Huahui Health: lead

Study Sites (1)

Nucleus Network

Brisbane, Queensland, Australia

Location

Study Officials

• Yongqing Lin

  Huahui Health Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 11, 2021
• Study Start: November 1, 2021
• Primary Completion: May 26, 2022
• Study Completion: August 2, 2022
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

AU (1)