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

Nxera Pharma UK Limited

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: HTL0022562

Study type: Interventional

Funder types: Industry

Identifiers

NCT04941989

2020-002887-30 (EudraCT Number)

246780 (Other Identifier)

HTL0022562-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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33 participants in 2 patient groups

Part 1 Single Ascending Dose

Experimental group

Description:

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.

Treatment:

Drug: HTL0022562

Drug: Placebo

Part 2 Multiple Ascending Dose

Experimental group

Description:

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.

Treatment:

Drug: HTL0022562

Drug: Placebo