Health TrialsbyHealthPanel

A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response

ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAdaxion Therapeutics

About this trial

This is a phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of subcutaneous and intravenous ADX-001 in healthy adult participants

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Provide informed consent - Be willing and able to sign a consent form after understanding the study and before any study-related procedures are performed.

Age - Be a healthy adult male or female aged 18 to 55 years.

Body weight and BMI - Have a Body Mass Index (BMI) between 18.0 and 32.0 kg/m². Weigh more than 50 kg and less than 120 kg.

For women who can become pregnant - Have a negative pregnancy test before participating.

Disqualifiers

Medical Conditions

You have a serious or ongoing health condition affecting the heart, lungs, liver, kidneys, digestive system, hormones, nervous system, immune system, or mental health.

You have a history of severe allergic reactions, anaphylaxis, or are allergic to the study drug or its ingredients.

Infections

Trial design

Design model

Parallel

Treatments tested in this trial

  • ADX-001

    Drug

    ADX-001 administered as a single dose according to the assigned cohort and route of administration (SC or IV).

  • ADX-001

    Drug

    ADX-001 administered every 4 weeks (Q4W) for a total of 4 doses according to the assigned cohort and route of administration (SC or IV).

  • Placebo

    Drug

    Matching placebo administered by SC injection or IV infusion according to the route and dosing schedule of the assigned cohort.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: SAD Cohort 1-5Experimental treatment 2 interventions
Group B: MAD Cohort 6-9Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence and severity of Treatment Emergent Adverse Events (TEAEs) of single and multiple doses of ADX-001 administered by subcutaneous and intravenous injection

Time frame
From first dose through Day 365 for participants receiving a single dose and through Day 505 for participants receiving multiple doses.

Secondary outcomes

1

PK Parameters peak concentration (Cmax) - SAD

Time frame
Pre-dose on Day 1 through Day 365
2

PK Parameters peak concentration (Cmax) - MAD

Time frame
Pre-dose on Day 1 through Day 87
3

Area under the concentration-time curve (AUC0-t) - SAD

Time frame
Pre-dose on Day 1 through Day 365
4

Area under the concentration-time curve (AUC0-t) - MAD

Time frame
Pre-dose on Day 1 through Day 87

Other outcomes

Sponsors and contacts

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

Adaxion Therapeutics

Lead sponsor

Source ClinicalTrials.gov
Apply now