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Not yet recruitingNCT07865442Updated Oct 8, 2026

First in Human, Randomized, Blinded, Placebo-Controlled Single Ascending Dose Study of ALT-01 in Healthy Participants

A Phase 1 interventional study of ALT-01 and Placebo in Autoimmune Disease, sponsored by Altis Medicines, Inc. Not yet recruiting at 1 site in Australia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Altis Medicines, Inc · Phase 1, Interventional, and Treatment

Updated Oct 8, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Autoimmune Disease

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03

In context

Autoimmune Diseases

655 studies on the registry are indexed under Autoimmune Diseases; 275 are open to participants now.

This study's planned enrollment of 50 is above the median of 40 across 427 interventional studies indexed under Autoimmune Diseases.

Browse Autoimmune Diseases studies →

Lead sponsor

This is the only study on the registry with Altis Medicines, Inc as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria:

  1. Willingness to provide written informed consent and comply with the intervention and all study assessments
  2. Age 18 to 65
  3. Body mass index (BMI) ≥ 18 to 32 kg/m2
  4. Healthy adults

Key Exclusion Criteria:

  1. Women who are pregnant or lactating
  2. 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)
  3. Donation or loss of ≥ 450 mL of blood, platelets or plasma within 3 months prior to randomization
  4. Any condition that prevents the participant from complying with study procedures
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    ALT-01 Dose A

    Subcutaneous injection

    Drug: ALT-01 · Drug: Placebo

  • Experimental
    ALT-01 Dose B

    Subcutaneous injection

    Drug: ALT-01 · Drug: Placebo

  • Experimental
    ALT-01 Dose C

    Subcutaneous injection

    Drug: ALT-01 · Drug: Placebo

  • Experimental
    ALT-01 Dose D

    Subcutaneous injection

    Drug: ALT-01 · Drug: Placebo

  • Experimental
    ALT-01 Dose E

    Subcutaneous injection

    Drug: ALT-01 · Drug: Placebo

  • Experimental
    ALT-01 Dose F

    Subcutaneous injection

    Drug: ALT-01 · Drug: Placebo

  • Experimental
    ALT-01 Dose G

    Subcutaneous injection

    Drug: ALT-01 · Drug: Placebo

Interventions

  • DrugALT-01

    Subcutaneous injection

  • DrugPlacebo

    Subcutaneous injection

06

What researchers measure

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 PK 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.

07

Study locations

1 site
  • Altis Site
    Adelaide, South Australia 5000, Australia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07865442
Lead sponsor
Altis Medicines, Inc
Responsible party
Sponsor
First posted
Oct 8, 2026
Start date
Oct 26, 2026 (estimated)
Primary completion
Sep 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Oct 8, 2026

Study contacts

Altis Study Director
Contact
info@altismedicines.com
617-302-6406

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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