A Study in Healthy Subjects to Assess the Safety, Tolerability and Pharmacokinetics of HTL0022562

NCT04941989 | Terminated Phase 1

• 3 other identifiers: HTL0022562-1012020-002887-30246780
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1, randomised, double-blind, first in human, two part, single centre, placebo controlled, single and multiple ascending dose trial in healthy adult subjects to evaluate the safety, tolerability and pharmacokinetics of HTL0022562.

Conditions

Healthy

Keywords

First in Human; Single Ascending Dose; Multiple Ascending Dose

Outcome Measures

Primary Outcomes (1)

• Number of Treatment Emergent Adverse Events (TEAEs)

  All Adverse Events (AEs), including clinical laboratory, vitals signs, body temperature, respiratory rate, physical examinations, local tolerability and site injection reactions, and ECGs will be analyzed in all subjects.

  Screening up to post last dose: Day 8 (Part 1) / Day 15 (Part 2)

Secondary Outcomes (4)

• Part 1 and Part 2: Cmax

  Part 1 up to Day 8, Part 2 up to Day 15

• Part 1 and Part 2: Tmax

  Part 1 up to Day 8, Part 2 up to Day 15

• Part 1 and Part 2: Area Under Curve (AUC)

  Part 1 up to Day 8, Part 2 up to Day 15

• Part 1 and Part 2: Ae

  Part 1 up to Day 8, Part 2 up to Day 15

Study Arms (2)

Part 1 Single Ascending Dose

EXPERIMENTAL

Eight subjects in up to 7 cohorts will be dosed. One or more subcutaneous injections of HTL0022562 will be administered. In each cohort, 6 subjects will receive HTL0022562 and 2 subjects will receive placebo.

Drug: HTL0022562; Drug: Placebo

Part 2 Multiple Ascending Dose

EXPERIMENTAL

Eight subjects in up to 4 cohorts will be dosed, following safety, tolerability and pharmacokinetic (PK) review of completed dose of Single Ascending Dose Cohort 5. In each cohort, 6 subjects will receive HTL0022562 and 2 subjects will receive placebo.

Drug: HTL0022562; Drug: Placebo

Interventions

HTL0022562 DRUG

HTL0022562

Part 1 Single Ascending Dose; Part 2 Multiple Ascending Dose

Placebo DRUG

Placebo

Part 1 Single Ascending Dose; Part 2 Multiple Ascending Dose

Eligibility Criteria

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

You may qualify if:

• Healthy males or healthy females of non-childbearing potential (WoNCBP) aged 18 to 55 years inclusive, with a body mass index \>18.5-\<30kgm2 and body weight ≥50kg.
• Healthy on the basis of a clinical history, physical examination, electrocardiogram (ECG), vital signs and laboratory tests of blood and urine.
• Willingness to comply with requirements or the trial, including contraception requirements.
• Able to give fully informed consent.

You may not qualify if:

• Confirmed current Coronavirus Disease 2019 (COVID 19) infection before randomisation.
• Clinical signs and symptoms consistent with COVID 19 (e.g. fever, dry cough, dyspnoea, sore throat, or fatigue) or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening or on admission.
• Suffered from severe course of COVID 19 (extracorporeal membrane oxygenation (ECMO), mechanically ventilated).
• Receipt of any investigational medicinal product (IMP) in a clinical research study within the previous 3 months (or 5 half-lives, whichever is longer) of Screening.
• Any abnormalities on 12-lead ECG or BP at Screening (as specified).
• History of any drug or alcohol abuse in the past 2 years.
• Vital signs outside the normal range for healthy volunteers
• Clinically significant abnormal biochemistry, haematology, coagulation, or urinalysis
• Abnormal renal function, hepatic function or history of abnormal hepatic function occurring during treatment with investigational or licensed drugs, which led to permanent discontinuation of treatment.
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti HCV), or human immunodeficiency virus (HIV)
• History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, or current hepatic renal dysfunction as judged by the investigator.
• Risk factor for ischaemic heart disease or cerebrovascular disease.
• Failure to satisfy, in the Investigator's judgement, the subject's fitness to participate for any other reason, including previous serious adverse reaction or serious hypersensitivity reactions to any drug or formulation excipients administered parenterally or orally.
• All female subjects must have a negative serum and urine pregnancy test at Screening and admission, respectively.

Sponsors & Collaborators

• Nxera Pharma UK Limited: lead

Study Sites (1)

Parexel Early Phase Clinical Unit

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

Study Design

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

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 28, 2021
• Study Start: May 25, 2021
• Primary Completion: November 19, 2021
• Study Completion: November 19, 2021
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)