Health TrialsbyHealthPanel

Phase 1 Study of ADX-626 in Healthy Participants

ConditionHealthy Adult Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorADARx Pharmaceuticals, Inc.

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • ADX-626

    Drug

    siRNA duplex oligonucleotide

  • Placebo

    Drug

    Saline

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: ADX-626Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety of ADX-626 in Healthy Participants

Incidence, relationship and severity of adverse events and serious adverse events

Time frame
Day 1 to Day 365

Secondary outcomes

1

Pharmacokinetics (PK) of ADX-626 - Maximum Concentration

Cmax

Time frame
Day 1 to Day 29
2

Pharmacokinetics (PK) of ADX-626 - Time to Maximum Concentration

Tmax

Time frame
Day 1 to Day 29
3

Pharmacokinetics (PK) of ADX-626 - Exposure

Area Under the Curve (AUC)

Time frame
Day 1 to Day 29
4

Pharmacodynamics (PD) of ADX-626 - Factor XI

Change from baseline in Factor XI measurements

Time frame
Day 1 to Day 365

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ADARx Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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