HealthyPhase 1NCT04941989
A Study in Healthy Subjects to Assess the Safety, Tolerability and Pharmacokinetics of HTL0022562
A Phase 1 study testing HTL0022562 in people with Healthy, run by Nxera Pharma UK Limited at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HTL0022562
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 May 2021to 19 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Parexel Early Phase Clinical Unit
Harrow, Middlesex, HA1 3UJ
About this study
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
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.
Read the 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
- Being tested
- HTL0022562, Placebo
- Keywords
- First in Human, Single Ascending Dose, Multiple Ascending Dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTL0022562Drug
HTL0022562
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: HTL0022562; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening up to post last dose: Day 8 (Part 1) / Day 15 (Part 2)
Secondary outcomes (4)
Part 1 and Part 2: Cmax
Plasma pharmacokinetic parameter: maximum systemic concentration of HTL0022562
Measured: Part 1 up to Day 8, Part 2 up to Day 15
Part 1 and Part 2: Tmax
Plasma pharmacokinetic parameter: time to Cmax of HTL0022562
Plasma pharmacokinetic parameter: time to Cmax of HTL0022562
Measured: Part 1 up to Day 8, Part 2 up to Day 15
Part 1 and Part 2: Area Under Curve (AUC)
Plasma pharmacokinetic parameter: Area under the plasma concentration versus time curve derived from systemic concentrations of HTL0022562
Measured: Part 1 up to Day 8, Part 2 up to Day 15
Part 1 and Part 2: Ae
Urine pharmacokinetic parameter: Amount of HTL0022562 recovered in urine for each urine collection interval
Measured: Part 1 up to Day 8, Part 2 up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start25 May 2021
- Primary completion19 Nov 2021
- Study completion19 Nov 2021
Why it stopped: Early termination of study pending evaluation of emerging preclinical profile.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nxera Pharma UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941989
- Sponsor's protocol ID
- HTL0022562-101
- Other IDs
- 2020-002887-30, 246780
- Status last verified
- Feb 2025
- First submitted
- 8 Jun 2021
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04941989
- Acronym / sponsor ID
- HTL0022562-101
- Conditions
- Healthy
- Keywords
- First in Human, Single Ascending Dose, Multiple Ascending Dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination of study pending evaluation of emerging preclinical profile.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Nxera Pharma UK LimitedIndustry (pharma, biotech, devices)
- Study start
- 25 May 2021 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 Single Ascending Dose | Experimental | Drug: HTL0022562, Drug: PlaceboEight 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. |
| Part 2 Multiple Ascending Dose | Experimental | Drug: HTL0022562, Drug: PlaceboEight 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HTL0022562HTL0022562 | Drug | Part 1 Single Ascending Dose, Part 2 Multiple Ascending Dose |
| PlaceboPlacebo | Drug | Part 1 Single Ascending Dose, Part 2 Multiple Ascending Dose |
Primary outcome
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: Screening up to post last dose: Day 8 (Part 1) / Day 15 (Part 2)
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.
4 secondary outcomes
Part 1 and Part 2: Cmax
Time frame: Part 1 up to Day 8, Part 2 up to Day 15
Part 1 and Part 2: Tmax
Time frame: Part 1 up to Day 8, Part 2 up to Day 15
Part 1 and Part 2: Area Under Curve (AUC)
Time frame: Part 1 up to Day 8, Part 2 up to Day 15
Part 1 and Part 2: Ae
Time frame: Part 1 up to Day 8, Part 2 up to Day 15
Results and safety
The study was stopped early (reason given: Early termination of study pending evaluation of emerging preclinical profile.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HTL0022562 in people with Healthy, run by Nxera Pharma UK Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Early termination of study pending evaluation of emerging preclinical profile.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment Emergent Adverse Events (TEAEs) (time frame: Screening up to post last dose: Day 8 (Part 1) / Day 15 (Part 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.