Autoimmune DiseasePhase 1NCT07865442
First in Human Study of ALT-01 in Healthy Participants
A Phase 1 study testing ALT-01 in people with Autoimmune Disease, run by Altis Medicines, Inc at 1 site in Australia.
Trial summary
The primary objective of the study is to evaluate the safety and tolerability of ALT-01 in healthy participants Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Disease
- What is being tested?
- ALT-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- 26 Oct 2026to 30 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: First in Human, Randomized, Blinded, Placebo-Controlled Single Ascending Dose Study of ALT-01 in Healthy Participants
The primary objective of the study is to evaluate the safety and tolerability of ALT-01 in healthy participants
- Conditions
- Autoimmune Disease
- Being tested
- ALT-01, Placebo
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALT-01Drug
Subcutaneous injection
PlaceboDrug
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| ALT-01 Dose A | Experimental | Subcutaneous injection Receives: Drug: ALT-01; Drug: Placebo |
| ALT-01 Dose B | Experimental | Subcutaneous injection Receives: Drug: ALT-01; Drug: Placebo |
| ALT-01 Dose C | Experimental | Subcutaneous injection Receives: Drug: ALT-01; Drug: Placebo |
| ALT-01 Dose D | Experimental | Subcutaneous injection Receives: Drug: ALT-01; Drug: Placebo |
| ALT-01 Dose E | Experimental | Subcutaneous injection Receives: Drug: ALT-01; Drug: Placebo |
| ALT-01 Dose F | Experimental | Subcutaneous injection Receives: Drug: ALT-01; Drug: Placebo |
| ALT-01 Dose G | Experimental | Subcutaneous injection Receives: Drug: ALT-01; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of TEAEs (treatment-emergent adverse events)
To evaluate the safety and tolerability of ALT-01 in healthy participants
Measured: From first dose of study drug through End of Study Visit/Early Termination Visit. End of Study is Day 169.
Secondary outcomes (3)
PK Parameters -- Tmax
To evaluate the Pharmacokinetics parameters through plasma concentration - Time to Maximum Concentration (Tmax)
Measured: From first dose of study drug through End of Study/Early Termination Visit. End of Study is Day 169.
PK Parameters -- AUC
To evaluate the PK parameters through plasma concentration- Area Under the Curve (AUC)
Measured: From first dose of study drug through End of Study/Early Termination Visit. End of Study is Day 169.
PK Parameters -- Cmax
To evaluate the PK parameters through plasma concentration- Maximum Concentration (Cmax)
Measured: From first dose of study drug through End of Study/Early Termination Visit. End of Study is Day 169.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start26 Oct 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Altis Medicines, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865442
- Sponsor's protocol ID
- ALT-01-101
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Human, Randomized, Blinded, Placebo-Controlled Single Ascending Dose Study of ALT-01 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07865442
- Acronym / sponsor ID
- ALT-01-101
- Conditions
- Autoimmune Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Altis Medicines, IncIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the safety and tolerability of ALT-01 in healthy participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| ALT-01 Dose A | Experimental | Drug: ALT-01, Drug: PlaceboSubcutaneous injection |
| ALT-01 Dose B | Experimental | Drug: ALT-01, Drug: PlaceboSubcutaneous injection |
| ALT-01 Dose C | Experimental | Drug: ALT-01, Drug: PlaceboSubcutaneous injection |
| ALT-01 Dose D | Experimental | Drug: ALT-01, Drug: PlaceboSubcutaneous injection |
| ALT-01 Dose E | Experimental | Drug: ALT-01, Drug: PlaceboSubcutaneous injection |
| ALT-01 Dose F | Experimental | Drug: ALT-01, Drug: PlaceboSubcutaneous injection |
| ALT-01 Dose G | Experimental | Drug: ALT-01, Drug: PlaceboSubcutaneous injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALT-01Subcutaneous injection | Drug | ALT-01 Dose A, ALT-01 Dose B, ALT-01 Dose C, ALT-01 Dose D, ALT-01 Dose E, ALT-01 Dose F, ALT-01 Dose G |
| PlaceboSubcutaneous injection | Drug | ALT-01 Dose A, ALT-01 Dose B, ALT-01 Dose C, ALT-01 Dose D, ALT-01 Dose E, ALT-01 Dose F, ALT-01 Dose G |
Primary outcome
Incidence of TEAEs (treatment-emergent adverse events)
Time frame: From first dose of study drug through End of Study Visit/Early Termination Visit. End of Study is Day 169.
To evaluate the safety and tolerability of ALT-01 in healthy participants
3 secondary outcomes
PK Parameters -- Tmax
Time frame: From first dose of study drug through End of Study/Early Termination Visit. End of Study is Day 169.
PK Parameters -- AUC
Time frame: From first dose of study drug through End of Study/Early Termination Visit. End of Study is Day 169.
PK Parameters -- Cmax
Time frame: From first dose of study drug through End of Study/Early Termination Visit. End of Study is Day 169.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALT-01 in people with Autoimmune Disease, run by Altis Medicines, Inc at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Altis Study Director (617-302-6406, info@altismedicines.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of TEAEs (treatment-emergent adverse events) (time frame: From first dose of study drug through End of Study Visit/Early Termination Visit. End of Study is Day 169.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.