Multiple SclerosisPhase 1/2NCT07826689
A Phase 1/2a Study of Oral PRO-1562 in Healthy Subjects and Patients With Relapsing Multiple Sclerosis
A Phase 1/2 study testing PRO-1562 Oral Capsules in people with Multiple Sclerosis, run by Progentos Therapeutics at 1 site in Australia.
Trial summary
Phase 1 will test single oral doses of PRO-1562 in healthy adult subjects to characterize the safety and the amount of drug that is absorbed into the body. Some subjects will have lumbar punctures performed to measure the amount of drug that crosses the blood-brain barrier since that is the site of drug activity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- PRO-1562 Oral Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2026to Feb 2029
- Phase
- Phase 1/2
- 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
Phase 1 Inclusion Criteria:
- Able and willing to provide written informed consent
- Body weight ≥ 48 kg (105.6 lbs) and body mass index (BMI) ≥ 18.5 and ≤ 30 kg/m2
- Must be in good health and without clinically significant abnormalities by review of medical and surgical history, physical examination, vital signs measurement, and 12-lead ECG
- No clinically-significant laboratory abnormalities
- Willing and able to use highly-effective forms of contraception for at least 30 days after the end of study visit.
Phase 1 Exclusion Criteria:
- Ongoing medical condition requiring systemic therapy.
- Ongoing infection
- mRNA or live vaccine during the past 60 days
- History of significant hypersensitivity, intolerance, or allergy to any drug/medication
- Participation in another clinical trial with an investigational agent within 30 days prior to Check-in or 5 half-lives (if known) of the investigational drug's PK, PD, or biological activity (if known), whichever is longer
- Positive alcohol breath test or urine screen for drugs of abuse.
- Use or intent to use natural products or nutritional/dietary supplements (including St. John's wort), vitamins, minerals, and phytotherapeutic /herbal/plant-derived preparations within or received within 14 days or 5 half-lives prior to Check-in, whichever is longer.
- Poor peripheral venous access.
- Receipt of blood products within 2 months prior to Check-in.
- Donation of blood or blood products during the 4 weeks prior to Check-in.
- Participants who in the opinion of the Principal Investigator (or designee), should not participate in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
CMAX Clinical Research
Adelaide, South Australia, 5000
Study Director, 61 1800 150 433, cmax@cmax.com.au
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1/2a Trial of PRO-1562 in Healthy Adults and Adults With Multiple Sclerosis and Chronic Optic Neuropathy
Phase 1 will test single oral doses of PRO-1562 in healthy adult subjects to characterize the safety and the amount of drug that is absorbed into the body. Some subjects will have lumbar punctures performed to measure the amount of drug that crosses the blood-brain barrier since that is the site of drug activity.
Phase 2a will be a 6-month trial to test the ability of once monthly dosing of PRO-1562 to promote remyelination of the CNS and provide clinical benefit to adult patients with relapsing multiple sclerosis (RMS) who also have long-term vision problems diagnosed as chronic optic neuropathy. The benefits of remyelination will be measured using tests of visual acuity, speed of optic nerve conduction signals, and clinical assessments of cognitive and motor function. PRO-1562 will be added on to a stable regimen of MS disease modifying therapy.
Read the detailed description
Phase 1 is a randomized, double-blind, placebo-controlled, single-ascending dose (SAD) trial of PRO-1562 in healthy adult participants at a single clinical research unit to characterize the safety and pharmacokinetics of a range of oral doses of PRO-1562. Phase 2a is a randomized, double-blind, placebo-controlled, multi-center, 6-month trial of PRO-1562 in adult patients with relapsing multiple sclerosis who also have chronic optic neuropathy. Patients will remain on their stable regimen of an approved MS disease modifying therapy during the trial. Oral PRO-1562 or placebo will be dosed once a month at scheduled clinic visits. Participants will be given the option to continue on their assigned study treatment after completing the 6-month treatment period until the last patient completes the 6-month treatment period.
- Conditions
- Multiple Sclerosis
- Being tested
- PRO-1562 Oral Capsules, Placebo Oral Capsule
- Keywords
- relapsing multiple sclerosis, chronic optic neuropathy, Remyelination
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO-1562 Oral CapsulesDrug
Oral, CNS-penetrant small molecule designed to induce remyelination
Placebo Oral CapsuleDrug
Placebo filled capsules that look like the active intervention
| Study group | Role | What they receive |
|---|---|---|
| Phase 1, PRO-1562 Dose level 1 | Experimental | PRO-1562 oral capsule Receives: Drug: PRO-1562 Oral Capsules |
| Phase 1, PRO-1562 Dose level 2 | Experimental | PRO-1562 oral capsule Receives: Drug: PRO-1562 Oral Capsules |
| Phase 1, PRO-1562 Dose level 3 | Experimental | PRO-1562 oral capsule Receives: Drug: PRO-1562 Oral Capsules |
| Phase 1, PRO-1562 Dose level 4 | Experimental | PRO-1562 oral capsules Receives: Drug: PRO-1562 Oral Capsules |
| Phase 1, PRO-1562 Dose level 5 | Experimental | PRO-1562 oral capsule Receives: Drug: PRO-1562 Oral Capsules |
| Phase 1, PRO-1562 Dose level 6 | Experimental | PRO-1562 oral capsule Receives: Drug: PRO-1562 Oral Capsules |
| Phase 1, Placebo | Placebo comparator | Placebo oral capsule Receives: Drug: Placebo Oral Capsule |
| Phase 2, PRO-1562 Oral Capsules Dose level 1 | Experimental | PRO-1562 low dose level selected from Phase 1 (oral capsule) Receives: Drug: PRO-1562 Oral Capsules |
| Phase 2, PRO-1562 Oral Capsules Dose level 2 | Experimental | PRO-1562 high dose level selected from Phase 1 (oral capsule) Receives: Drug: PRO-1562 Oral Capsules |
| Phase 2, Placebo | Placebo comparator | Placebo oral capsule Receives: Drug: Placebo Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 Incidence of ≥Grade 2 treatment-emergent adverse events
Incidence of treatment-emergent adverse events including clinically significant laboratory abnormalities of ≥Grade 2 in healthy participants
Measured: From enrollment until 7 days post dose
Phase 2 Change from baseline P100 VEP latency
The change from baseline on visual evoked potential (VEP) in affected eye of RMS patients after 6 months of study treatment
Measured: From enrollment until the end of 6 months of treatment
Secondary outcomes (3)
Area under the concentration-time curve of PRO-1562 (Phase 1)
Concentration over time analysis to determine overall exposure to PRO-1562 by dose group
Measured: From enrollment until 7 days post dose.
Brain myelin content, change from baseline
MRI measurement of brain myelin content in multiple brain regions will be determined as baseline and after 6 months of treatment
Measured: From enrollment to the end of 6 months of treatment
Safety Phase 2 Incidence of ≥Grade 2 treatment-emergent adverse events
Incidence of treatment emergent adverse events including clinically significant laboratory abnormalities of ≥Grade 2 in RMS patients
Measured: From enrollment until the end of 6-months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Progentos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul A Frohna, MD, PhD, PharmD, Study chair, Progentos Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826689
- Sponsor's protocol ID
- PRO-1562-101
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 1/2a Trial of PRO-1562 in Healthy Adults and Adults With Multiple Sclerosis and Chronic Optic Neuropathy
- ClinicalTrials.gov ID
- NCT07826689
- Acronym / sponsor ID
- PRO-1562-101
- Conditions
- Multiple Sclerosis
- Keywords
- relapsing multiple sclerosis, chronic optic neuropathy, Remyelination
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Progentos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 17 Sep 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.
Phase 1 will test single oral doses of PRO-1562 in healthy adult subjects to characterize the safety and the amount of drug that is absorbed into the body. Some subjects will have lumbar punctures performed to measure the amount of drug that crosses the blood-brain barrier since that is the site of drug activity.
Phase 2a will be a 6-month trial to test the ability of once monthly dosing of PRO-1562 to promote remyelination of the CNS and provide clinical benefit to adult patients with relapsing multiple sclerosis (RMS) who also have long-term vision problems diagnosed as chronic optic neuropathy. The benefits of remyelination will be measured using tests of visual acuity, speed of optic nerve conduction signals, and clinical assessments of cognitive and motor function. PRO-1562 will be added on to a stable regimen of MS disease modifying therapy.
Detailed description
Phase 1 is a randomized, double-blind, placebo-controlled, single-ascending dose (SAD) trial of PRO-1562 in healthy adult participants at a single clinical research unit to characterize the safety and pharmacokinetics of a range of oral doses of PRO-1562. Phase 2a is a randomized, double-blind, placebo-controlled, multi-center, 6-month trial of PRO-1562 in adult patients with relapsing multiple sclerosis who also have chronic optic neuropathy. Patients will remain on their stable regimen of an approved MS disease modifying therapy during the trial. Oral PRO-1562 or placebo will be dosed once a month at scheduled clinic visits. Participants will be given the option to continue on their assigned study treatment after completing the 6-month treatment period until the last patient completes the 6-month treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Phase 1, PRO-1562 Dose level 1 | Experimental | Drug: PRO-1562 Oral CapsulesPRO-1562 oral capsule |
| Phase 1, PRO-1562 Dose level 2 | Experimental | Drug: PRO-1562 Oral CapsulesPRO-1562 oral capsule |
| Phase 1, PRO-1562 Dose level 3 | Experimental | Drug: PRO-1562 Oral CapsulesPRO-1562 oral capsule |
| Phase 1, PRO-1562 Dose level 4 | Experimental | Drug: PRO-1562 Oral CapsulesPRO-1562 oral capsules |
| Phase 1, PRO-1562 Dose level 5 | Experimental | Drug: PRO-1562 Oral CapsulesPRO-1562 oral capsule |
| Phase 1, PRO-1562 Dose level 6 | Experimental | Drug: PRO-1562 Oral CapsulesPRO-1562 oral capsule |
| Phase 1, Placebo | Placebo comparator | Drug: Placebo Oral CapsulePlacebo oral capsule |
| Phase 2, PRO-1562 Oral Capsules Dose level 1 | Experimental | Drug: PRO-1562 Oral CapsulesPRO-1562 low dose level selected from Phase 1 (oral capsule) |
| Phase 2, PRO-1562 Oral Capsules Dose level 2 | Experimental | Drug: PRO-1562 Oral CapsulesPRO-1562 high dose level selected from Phase 1 (oral capsule) |
| Phase 2, Placebo | Placebo comparator | Drug: Placebo Oral CapsulePlacebo oral capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| PRO-1562 Oral CapsulesOral, CNS-penetrant small molecule designed to induce remyelination | Drug | Phase 1, PRO-1562 Dose level 1, Phase 1, PRO-1562 Dose level 2, Phase 1, PRO-1562 Dose level 3, Phase 1, PRO-1562 Dose level 4, Phase 1, PRO-1562 Dose level 5, Phase 1, PRO-1562 Dose level 6, Phase 2, PRO-1562 Oral Capsules Dose level 1, Phase 2, PRO-1562 Oral Capsules Dose level 2 |
| Placebo Oral CapsulePlacebo filled capsules that look like the active intervention | Drug | Phase 1, Placebo, Phase 2, Placebo |
Primary outcome
Phase 1 Incidence of ≥Grade 2 treatment-emergent adverse events
Time frame: From enrollment until 7 days post dose
Incidence of treatment-emergent adverse events including clinically significant laboratory abnormalities of ≥Grade 2 in healthy participants
Phase 2 Change from baseline P100 VEP latency
Time frame: From enrollment until the end of 6 months of treatment
The change from baseline on visual evoked potential (VEP) in affected eye of RMS patients after 6 months of study treatment
3 secondary outcomes
Area under the concentration-time curve of PRO-1562 (Phase 1)
Time frame: From enrollment until 7 days post dose.
Brain myelin content, change from baseline
Time frame: From enrollment to the end of 6 months of treatment
Safety Phase 2 Incidence of ≥Grade 2 treatment-emergent adverse events
Time frame: From enrollment until the end of 6-months of treatment
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 29 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Paul A Frohna, MD, PhD, PharmD study chair
Progentos Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PRO-1562 Oral Capsules in people with Multiple Sclerosis, run by Progentos Therapeutics 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?
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: looking for participants now, as of the sponsor's last update on 29 Sep 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Chief Medical Officer (858-306-2085, pfrohna@progentos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 Incidence of ≥Grade 2 treatment-emergent adverse events (time frame: From enrollment until 7 days post dose). The study lists 2 primary outcomes in all. 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 29 Sep 2026.