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

NCT ID: NCT04941989

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-25
• Study Completion Date: 2021-11-19

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.

Detailed Description

This is a first in human, two part, double blind, placebo controlled, randomised single and multiple ascending subcutaneous dose study to evaluate the safety, tolerability and pharmacokinetics of HTL0022562.

Part 1 comprises of 7 sequential ascending dosing cohorts and Part 2 comprises of 4 multiple ascending dosing cohorts.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part 1 Single Ascending Dose

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.

Group Type: EXPERIMENTAL

HTL0022562

Intervention Type: DRUG

HTL0022562

Placebo

Intervention Type: DRUG

Placebo

Part 2 Multiple Ascending Dose

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.

Group Type: EXPERIMENTAL

HTL0022562

Intervention Type: DRUG

HTL0022562

Placebo

Intervention Type: DRUG

Placebo

Interventions

HTL0022562

HTL0022562

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nxera Pharma UK Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Parexel Early Phase Clinical Unit

Harrow, Middlesex, United Kingdom

Countries

United Kingdom

Other Identifiers

2020-002887-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

246780

Identifier Type: OTHER

Identifier Source: secondary_id

HTL0022562-101

Identifier Type: -

Identifier Source: org_study_id