CompletedPhase 1

A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants

New Zealand42 participantsStarted 2017-09-07

Plain-language summary

This is a Phase 1 first-in-human (FIH) study evaluating single and multiple dose administration of AL-034 in healthy adult participants. The aim is to examine the safety (including pharmacodynamic \[PD\] biomarker assessments), tolerability, and pharmacokinetics (PK) of increasing single ascending doses (SADs) (Part 1) and multiple ascending doses (MADs) (Part 2) of AL-034. The potential food effect will be investigated in healthy adult participants at one or optionally 2 single dose level(s).

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

INCLUSION CRITERIA Each potential participant must satisfy all of the following criteria to be enrolled in the study * participant must be a man or a woman between 18 and 55 years of age, extremes included * Female participant must be of non-childbearing potential, defined as: a) Postmenopausal: A postmenopausal state is defined as no menses for 12 months without an alternative medical explanation. A high follicle stimulating hormone (FSH) level (greater than \[\>\]40 international unit per liter \[IU/L\] or milli international unit per milliliter \[mIU/mL\]) in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, 2 FSH measurements will have to be taken at least 3 months apart, OR b) Permanently sterile - permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy Male participants must either: a) be surgically sterile (have had a vasectomy), or otherwise incapable of fathering a child, OR b) if heterosexually active, have a partner who is postmenopausal (as defined above), permanently sterile (as defined above), or otherwise incapable of becoming pregnant, OR c) if heterosexually active with a woman of childbearing potential, agree to use effective methods of contraception as detailed in Prohibitions and Restrictions section, from screening onwards…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

Timeframe: Approximately up to 9 weeks

Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

Timeframe: Approximately up to 12 weeks

Part 1: Number of Participants With AEs by Severity

Timeframe: Approximately up to 9 weeks

Part 2: Number of Participants With AEs by Severity

Timeframe: Approximately up to 12 weeks

Part 1: Number of Participants with Clinically Significant Changes in Physical Examination

Timeframe: Approximately up to 9 weeks

Part 2: Number of Participants with Clinically Significant Changes in Physical Examination

Timeframe: Approximately up to 12 weeks

Part 1: Number of Participants with Vital Sign Abnormalities

Trial details

NCT IDNCT03285620

SponsorAlios Biopharma Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-11-14

View on ClinicalTrials.gov More Hepatitis B trials

Plain-language summary

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part 1: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

Timeframe: Approximately up to 9 weeks

Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

Timeframe: Approximately up to 12 weeks

Part 1: Number of Participants With AEs by Severity

Timeframe: Approximately up to 9 weeks

Part 2: Number of Participants With AEs by Severity

Timeframe: Approximately up to 12 weeks

Part 1: Number of Participants with Clinically Significant Changes in Physical Examination

Timeframe: Approximately up to 9 weeks

Part 2: Number of Participants with Clinically Significant Changes in Physical Examination

Timeframe: Approximately up to 12 weeks

Part 1: Number of Participants with Vital Sign Abnormalities