A Study to Evaluate the Safety, Tolerability, PK and PD of HNC1058

NCT05803850 | Completed Phase 1 FDA Drug

• 1 other identifier: HNC1058-A101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of HNC1058 given to healthy subjects, compared to placebo.

Conditions

IPF

Outcome Measures

Primary Outcomes (1)

• Number of subjects with adverse events and concomitant medications

  To evaluate the safety and tolerability of HNC1058 in comparison with placebo after a single oral dose in healthy subjects in terms of AEs and CMs.

  Between screening and 7-9 days after the last dose

Secondary Outcomes (2)

• Number of subjects with vital sign measurements

  Between screening and 7-9 days after the last dose

• Number of subjects with clinical laboratory test results

  Between screening and 7-9 days after the last dose

Study Arms (4)

HNC1058 Capsules

EXPERIMENTAL

HNC1058 Capsules, single ascending doses

Drug: HNC1058 Capsules

HNC1058 Placebos

PLACEBO COMPARATOR

HNC1058 Placebos, single ascending doses

Drug: HNC1058 Capsules

HNC1058 Capsules FED

EXPERIMENTAL

HNC1058 Capsules, food effect, Single dose

Drug: HNC1058 Capsules

HNC1058 Placebos FED

PLACEBO COMPARATOR

HNC1058 Placebos, food effect, Single dose

Drug: HNC1058 Capsules

Interventions

HNC1058 Capsules DRUG

HNC1058 Capsules/Placebos, single dose, PO, starting dose of 10 mg escalating up to 80 mg；HNC1058 Capsules/Placebos, 50 mg, single dose, FED.

Also known as: HNC1058 Placebos

HNC1058 Capsules; HNC1058 Capsules FED; HNC1058 Placebos; HNC1058 Placebos FED

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements, and restrictions of the study. Are capable of giving informed consent and complying with study procedures.
• Between the ages of 18 and 55 years (inclusive) at the time of Screening.
• BMI between 18.0 and 32.0 kg/m2 (inclusive) at the time of Screening and have a body weight no less than 50 kg.
• In good general health, as determined by the Investigator.
• Female subjects must be non pregnant and non lactating.
• Female subjects must be of non childbearing potential, or agree to use an appropriate method(s) of contraception throughout the entire duration of study participation, and have negative pregnancy test results at Screening (serum) and Admission (urine).
• Refer to Section 6.4.1 for full details of reproductive requirements and acceptable methods of contraception for female subjects.
• Male subjects with female partners of reproductive potential must agree to practice abstinence or to use a condom (male subject) plus an additional barrier method (female partner) of contraception for the duration of the study and for at least 90 days after dosing; must also agree to refrain from sperm donation for at least 90 days post dose.
• Normal renal function as determined by Investigator following review of clinical laboratory test results, including eGFR as estimated using the CKD EPI equation.
• Non smoker, with no use of any tobacco or nicotine containing products within 6 months prior to Day 1.

You may not qualify if:

• Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator.
• Known or suspected malignancy.
• History of pancreatitis or gall stones.
• History of unexplained syncope, symptomatic hypotension, or hypoglycemia.
• Family history of long QTc syndrome.
• History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance.
• Poor venous access.
• Positive blood screen for human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or hepatitis E.
• Hospital admission or major surgery within 6 months prior to screening.
• History of alcohol or prescription drug abuse within 9 months prior to screening.
• Positive test result for alcohol or drugs of abuse (i.e., UDS) at screening or Admission.
• Use of any prohibited medication(s) and/or substance(s), including:
• use of any drugs known to induce or inhibit drug metabolism within 30 days prior to Day 1;
• receipt of another investigational medication (EXCEPT biological compound) within 30 days or receipt of biological compound within 90 days (or 5 half lives, whichever is longer) prior to Day 1;
• participation in an investigational device study within 30 days prior to Day 1.

Sponsors & Collaborators

• Guangzhou Henovcom Bioscience Co. Ltd.: lead

Study Sites (1)

Syneos Health

Miami, Florida, 33136, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential Assignment

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 7, 2023
• Study Start: March 28, 2023
• Primary Completion: February 27, 2024
• Study Completion: March 8, 2024
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)