Health TrialsbyHealthPanel

First in Human Study of ALT-01 in Healthy Participants

ConditionAutoimmune Disease
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAltis Medicines, Inc

About this trial

The primary objective of the study is to evaluate the safety and tolerability of ALT-01 in healthy participants

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Willingness to provide written informed consent and comply with the intervention and all study assessments

Age 18 to 65

Body mass index (BMI) ≥ 18 to 32 kg/m2

Healthy adults

Disqualifiers

Women who are pregnant or lactating

Participation in any other investigational drug study and received the last dose of investigational drug within 30 days or 5 half-lives (whichever is longer)

Donation or loss of ≥ 450 mL of blood, platelets or plasma within 3 months prior to randomization

Any condition that prevents the participant from complying with study procedures

Trial design

Design model

Sequential

Treatments tested in this trial

  • ALT-01

    Drug

    Subcutaneous injection

  • Placebo

    Drug

    Subcutaneous injection

Treatment groups

50 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: ALT-01 Dose AExperimental treatment 2 interventions
Group B: ALT-01 Dose BExperimental treatment 2 interventions
Group C: ALT-01 Dose CExperimental treatment 2 interventions
Group D: ALT-01 Dose DExperimental treatment 2 interventions
Group E: ALT-01 Dose EExperimental treatment 2 interventions
Group F: ALT-01 Dose FExperimental treatment 2 interventions
Group G: ALT-01 Dose GExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of TEAEs (treatment-emergent adverse events)

To evaluate the safety and tolerability of ALT-01 in healthy participants

Time frame
From first dose of study drug through End of Study Visit/Early Termination Visit. End of Study is Day 169.

Secondary outcomes

1

PK Parameters -- Tmax

To evaluate the Pharmacokinetics parameters through plasma concentration - Time to Maximum Concentration (Tmax)

Time frame
From first dose of study drug through End of Study/Early Termination Visit. End of Study is Day 169.
2

PK Parameters -- AUC

To evaluate the PK parameters through plasma concentration- Area Under the Curve (AUC)

Time frame
From first dose of study drug through End of Study/Early Termination Visit. End of Study is Day 169.
3

PK Parameters -- Cmax

To evaluate the PK parameters through plasma concentration- Maximum Concentration (Cmax)

Time frame
From first dose of study drug through End of Study/Early Termination Visit. End of Study is Day 169.

Other outcomes

Sponsors and contacts

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

Altis Medicines, Inc

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: