UnknownPhase 2

Exploratory Dose Ranging Study Assessing APH-1501 for the Treatment of Opioid Addiction

32 participantsStarted 2023-10

Plain-language summary

The purpose of this study is determine the safety, efficacy and tolerability of a novel drug APH-1501 as a pharmacotherapy for Opioid Dependence. The investigators will evaluate the safety of escalating doses APH-1501.

Who can participate

Age range

21 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.

Exclusion criteria

. the safety or well-being of the participant or study staff;
. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
. the analysis of results

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

[Safety] Incidence of Treatment Emergent Adverse Effects

Timeframe: Baseline through 30 days post final treatment dose up to day 60

[Tolerability] Pharmacokinetics of APH-1501

Timeframe: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes post administered dose

[Tolerability] Pharmacokinetics of APH-1501

Timeframe: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes post first administered dose.

[Tolerability] Pharmacokinetics of APH-1501

Timeframe: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes post first administered dose.

Trial details

NCT IDNCT03813095

SponsorAphios

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09

Contact for this trial

Trevor P Castor

7819326933 tcastor@aphios.com

View on ClinicalTrials.gov More Addiction trials

Who can participate

Age range

21 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.

Exclusion criteria

. the safety or well-being of the participant or study staff;
. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
. the analysis of results

What they're measuring

[Safety] Incidence of Treatment Emergent Adverse Effects

Timeframe: Baseline through 30 days post final treatment dose up to day 60

[Tolerability] Pharmacokinetics of APH-1501

Timeframe: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes post administered dose

[Tolerability] Pharmacokinetics of APH-1501

Timeframe: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes post first administered dose.

[Tolerability] Pharmacokinetics of APH-1501

Timeframe: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes post first administered dose.