Loading clinical trials...

RECRUITINGPHASE1

Phase 1 Study of ADX-626 in Healthy Participants

A Phase 1, Randomized, Blinded, Placebo-Controlled Study to Assess ADX-626 in Healthy Participants

NCT07081503•ADARx Pharmaceuticals, Inc.

Summary

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).

Detailed Description

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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (1)

Richmond Pharmacology

London, United Kingdom

Key Dates

Start Date

August 12, 2025

Primary Completion Date

January 22, 2027

Completion Date

January 22, 2027

Last Updated

March 2, 2026

Enrollment

ESTIMATED participants

Conditions

Healthy Adult Participants

Interventions

ADX-626

DRUG

Placebo

DRUG

Contacts

Nali Castillo

CONTACT

858-333-9022 npak-castillo@adarx.com

Turkish Validity and Reliability Study of PRevention of Toxic Chemicals in the Environment for Children Tool

NCT07483606

Healthy Adult ParticipantsToxic Chemicals+1 more

View study

RECRUITINGPHASE1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

NCT06342713

Healthy ParticipantsHealthy Subjects+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase 1 Study of ADX-626 in Healthy Participants

Inclusion Criteria

Exclusion Criteria

Turkish Validity and Reliability Study of PRevention of Toxic Chemicals in the Environment for Children Tool

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

Evaluation of [18F]GATT-44 for Positron Emission Tomography Imaging of the GABA Transporter-1

A Clinical Trial to Study Single- and Multiple- Doses of GSM-779690T in Healthy Participants