Phase 1 Study of ADX-626 in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-12

Study Completion Date

2027-01-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This first-in-human study will evaluate the safety and tolerability of ADX-626 in healthy participants. The study will also look at how ADX-626 interacts with the human body (the pharmacokinetics and pharmacodynamics of ADX-626).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study Conducted in Healthy Male Subjects to Investigate the Safety and Tolerability of AC-76, Its Fate in the Body, and Its Effect on the Body

NCT03173625

Healthy Subjects

COMPLETED PHASE1

A Study to Evaluate the Safety, Tolerability and Amount of EI-1071 in Blood in Healthy Volunteers

NCT04238364

Healthy Volunteers

COMPLETED PHASE1

A Placebo-controlled Phase 1 Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-1014-6470 in Healthy Subjects

NCT04608513

Healthy

COMPLETED PHASE1

A Study to Determine the Safety and Tolerability of AG-236 and How it is Absorbed, Broken Down, and Eliminated From the Body in Healthy Participants

NCT07075640

Healthy Participants

RECRUITING PHASE1

Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of MBX 2109 in Healthy Adult Subjects

NCT05158335

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A Phase 1, first-in-human study to assess the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-626 compared with placebo in healthy participants.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Adult Participants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ADX-626

Group Type EXPERIMENTAL

ADX-626

Intervention Type DRUG

siRNA duplex oligonucleotide

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ADX-626

siRNA duplex oligonucleotide

Intervention Type DRUG

Placebo

Saline

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18 to 45 years at the time of informed consent
* Males or women of non-childbearing potential (WONCBP)
* Willing to comply with all study requirements while participating
* Suitable venous access for blood sampling.
* Body weight ≥ 50 kg and a body mass index (BMI) ≤25 kg/m2
* Normal laboratory results including liver enzymes, hemoglobin, platelet count, and coagulation parameters
* Willing to use acceptable contraception methods if applicable

Exclusion Criteria

* Significant medical condition such as hypertension, diabetes, cardiovascular disease, or cancer
* History of bleeding or coagulation disorders, prior instances of major bleeding, or a family history of bleeding disorders.
* Current infection
* Participation in an interventional drug study within the last 90 days

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes