Clinical trial NCT04941989: A Study in Healthy Subjects to Assess the Safety, Tolerability and Pharmacokinetics of HTL0022562
Official title: A Phase 1, Randomised, Double-Blind, Placebo-Controlled, First in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Subcutaneous HTL0022562 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: First in Human
Single Ascending Dose
Multiple Ascending Dose
Lead sponsor: Nxera Pharma UK Limited
Sponsor class: INDUSTRY
First posted: 2021-06-28
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: Screening up to post last dose: Day 8 (Part 1) / Day 15 (Part 2)
Secondary outcomes:
measure: Part 1 and Part 2: Cmax
timeFrame: Part 1 up to Day 8, Part 2 up to Day 15
measure: Part 1 and Part 2: Tmax
timeFrame: Part 1 up to Day 8, Part 2 up to Day 15
measure: Part 1 and Part 2: Area Under Curve (AUC)
timeFrame: Part 1 up to Day 8, Part 2 up to Day 15
measure: Part 1 and Part 2: Ae
timeFrame: Part 1 up to Day 8, Part 2 up to Day 15
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Parexel Early Phase Clinical Unit
state: Middlesex
Study officials:
References: