Mild to Moderate AsthmaPhase 1/2NCT07245368
Study of PRA-216 in Healthy Participants and Participants With Mild-to-Moderate Asthma
A Phase 1/2 study testing PRA-216 in people with Mild to Moderate Asthma, run by Prana Therapies Inc at 8 sites in 2 countries.
Trial summary
Phase 1 of this study will consist of 2 parts Part 1 will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 in healthy volunteers through single ascending dose administered by either intravenous (IV) or subcutaneous (SC). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild to Moderate Asthma
- What is being tested?
- PRA-216
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 4 Nov 2025to 31 Jan 2027
- 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
Who may be able to join
- Age 18-65
- Must be in good health with no significant medical history
- Willing and able to attend all study visits, comply with study requirements
- Able and willing to provide written informed consent
- Age 18-65
- Must be in good health with no significant medical history
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- Willing and able to attend all study visits, comply with study requirements.
- Able and willing to provide written informed consent
- Documented asthma diagnosis prior for at least 12 months prior to screening.
- Symptomatic asthma
- Currently receiving maintenance asthma medications
Who cannot join
- Evidence of clinically significant condition or disease
- Any physical or psychological condition that prohibits study completion
- Known history of illicit drug use or drug abuse, harmful alcohol use (at the Investigator's discretion), alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study agent
- History of severe allergic reactions or hypersensitivity
- Donation or loss of ≥ 1 unit of whole blood or plasma within 2 months prior to dosing
- Phase 2a
Show all 13Show fewer
- Evidence of clinically significant condition or disease
- Known history of illicit drug use or drug abuse, harmful alcohol use (at the Investigator's discretion), alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study agent
- Donation or loss of ≥ 1 unit of whole blood or plasma within 2 months prior to dosing
- History of severe allergic reactions or hypersensitivity
- Current or former smoker with a smoking history of ≥10 pack-years
- Receipt of immunosuppressant therapies or biologic therapy for asthma within 6 months of screening
- Other investigational agent(s) within 30 days of dosing
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
Australia5 sites, 5 recruiting
- Recruiting
Emertitus Research Sydney
Botany, New South Wales, 2019
Ronald Mak, MD, 0289648186, ronaldmak@emeritusresearch.com
- Recruiting
Emeritus Research Camberwell
Camberwell, Victoria, 3124
Sam Francis, MD, 0395096166, samfrancis@emeritusresearch.com
- Not yet recruiting
Monash Health
Clayton, Victoria, 3168
Phillip Bardin, 0395942279, philip.bardin@monashhealth.org
- Recruiting
Linear
Joondalup, Western Australia, 6027
011 61 88 6382 5110, enquiries@linear.org.au
- Recruiting
Linear
Nedlands, Western Australia, 6009
site contact, 08 6382 5110, enquiries@linear.org.au
New Zealand3 sites, 3 recruiting
- Recruiting
PCRN Waikato, Nawton
Hamilton, Auckland, 3200
Enrollment Coordinator, +64 07 960 2123, enquiries@clinicaltrialswaikato.co.nz
- Recruiting
Pacific Clinical Research Network-Auckland
Takapuna, Auckland, 0622
Enrollment Coordinator, +64 9 242 3321, Adminauckland@pcrn.co.nz
Auckland@pcrn.co.nz
- Recruiting
PCRN Wellington, Ebdentown
Upper Hutt, Auckland, 5018
Enrollment Coordinator, +64 4 9201800, clinicaltrials@uhhc.co.nz
About this study
Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Ascending and Multiple Ascending Dose Study Investigating PRA-216 in Healthy Volunteers Followed by a Phase 2a Randomized, Double-Blind, Placebo-Controlled Study in Participants With Mild-to-Moderate Asthma
Phase 1 of this study will consist of 2 parts
- Part 1 will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 in healthy volunteers through single ascending dose administered by either intravenous (IV) or subcutaneous (SC).
- Part 2 will evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of PRA-216 in healthy volunteers with repeat doses of multiple ascending dose administered subcutaneously.
Phase 2a of this study is a randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and immunogenicity of PRA-216 in participants with mild to moderate asthma. The dose of PRA-216 for this phase was determined from Phase 1.
Read the detailed description
This study is a Phase 1/2a randomized, double-blind, placebo-controlled, single- and multiple-dose study with staggered dose escalations in healthy participants and participants with mild to moderate asthma. Single-ascending dose (SAD) cohorts will be evaluated for one single dose administered. Multiple ascending dose (MAD) cohorts will be evaluated for repeat doses .
Participants with mild to moderate asthma will be recruited for Phase 2a of this study, to evaluate safety of randomized, double blind, placebo controlled PRA-216. The dose of PRA-216 for this phase was determined from Phase 1 safety, tolerability, and PK data. Additional dose levels or schedules may be used for Phase 2a, depending on data from Phase 1.
This study consists of 2 phases, as follows:
Phase 1, Part 1:
SAD in healthy volunteers. Study visits in this section will entail a single dose administration of PRA-216 or placebo and collection of study data.
Phase 1, Part 2:
MAD in healthy volunteers. Study visits in this section will entail repeat doses of PRA-216 or placebo and collection of study data.
Phase 2a Participants with mild to moderate asthma will receive PRA-216 or placebo.
- Conditions
- Mild to Moderate Asthma
- Being tested
- PRA-216, Placebo
- Keywords
- healthy volunteers, pharmacodynamics, immunogenicity, asthma, pharmacokinetics
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRA-216Drug
biologic
PlaceboDrug
matching placebo for PRA-216
| Study group | Role | What they receive |
|---|---|---|
| Phase 1, Part 1: SAD Cohorts: Active Drug | Experimental | Healthy volunteers will receive a single dose of PRA-216 in a dose escalation format. Receives: Drug: PRA-216 |
| Phase 1, Part 1: SAD Cohorts: Placebo | Placebo comparator | Healthy volunteers will receive a single dose of placebo Receives: Drug: Placebo |
| Phase 1, Part 2: MAD Cohort: Active Drug | Experimental | Healthy volunteers will receive repeated doses of PRA-216 in a dose escalation format. Receives: Drug: PRA-216 |
| Phase 1, Part 2 MAD Cohort: Placebo Comparator | Placebo comparator | Healthy volunteers will receive repeated doses of placebo comparator. Receives: Drug: Placebo |
| Phase 2a: Participants with mild to moderate asthma-active drug | Experimental | Participants with mild to moderate asthma will be randomized to receive repeat doses of PRA-216. Receives: Drug: PRA-216 |
| Phase 2a: Participants with mild to moderate asthma-placebo | Placebo comparator | Participants with mild to moderate asthma will be randomized to receive repeat doses of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Incidence, nature, and severity of serious adverse events (SAEs) with a single dose of PRA-216 in healthy volunteers (SAD arm)
Incidence, nature, and severity of serious adverse events (SAEs)
Measured: Up to Study Day 169
Phase 1: Incidence, nature, and severity of serious adverse events (SAEs) of multiple doses of PRA-216 in healthy volunteers (MAD arm)
Incidence, nature, and severity of and serious adverse events (SAEs)
Measured: up to Study Day 169
Phase 2a: To evaluate the effect of multiple doses of PRA-216 compared to placebo on exhaled nitric oxide (FeNO) in asthma participants
Fractional exhaled nitric oxide (FeNO) is a non-invasive biomarker of airway inflammation in asthma.
Measured: Up to Study Day 57
Secondary outcomes (9)
Phase 1: Immunogenicity of PRA-216: ADA in healthy volunteers
Incidence and magnitude of anti-drug antibody following single or multiple doses of PRA-216
Measured: Up to Study Day 169
Phase 1: Pharmacokinetics of PRA-216: Tmax in healthy volunteers
Time to maximum concentration of drug in plasma following single or multiple doses of PRA-216
Measured: Up to Study Day 169
Phase 1: Pharmacokinetics of PRA-216: AUC in healthy volunteers
Area under the curve following single or multiple doses of PRA-216
Measured: Up to Study Day 169
Phase 1: Pharmacokinetics of PRA-216: Cmax in healthy volunteers
Maximum concentration of PRA-216 in plasma following single or multiple doses of PRA-216.
Measured: Up to Study Day 169
Phase 2a: Incidence, nature, and severity of serious adverse events (SAEs) of PRA-216 in patients with asthma
Incidence, nature, and severity of serious adverse events (SAEs)
Measured: Up to Study Day 197
Phase 2a: Immunogenicity of PRA-216: ADA in patients with asthma
Incidence and magnitude of anti-drug antibody following drug administration
Measured: Up to Study Day 197
Phase 2a: Pharmacokinetics of PRA-216: Tmax in patients with asthma
Time to maximum concentration of drug in plasma following multiple doses of PRA-216
Measured: Up to Study Day 197
Phase 2a: Pharmacokinetics of PRA-216: AUC in patients with asthma
Area under the curve of PRA-216 following multiple doses of PRA-216
Measured: Up to Study Day 197
Phase 2a: Pharmacokinetics of PRA-216: Cmax in patients with asthma
Maximum concentration in plasma of PRA-216 following multiple doses
Measured: Up to Study Day 197
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start4 Nov 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate AsthmaStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prana Therapies Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245368
- Sponsor's protocol ID
- PRA-216-101
- Status last verified
- Aug 2026
- First submitted
- 17 Nov 2025
- Last updated
- 6 Aug 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 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Ascending and Multiple Ascending Dose Study Investigating PRA-216 in Healthy Volunteers Followed by a Phase 2a Randomized, Double-Blind, Placebo-Controlled Study in Participants With Mild-to-Moderate Asthma
- ClinicalTrials.gov ID
- NCT07245368
- Acronym / sponsor ID
- PRA-216-101
- Conditions
- Mild to Moderate Asthma
- Keywords
- healthy volunteers, pharmacodynamics, immunogenicity, asthma, pharmacokinetics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Prana Therapies IncIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 24 Nov 2025 (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 of this study will consist of 2 parts
- Part 1 will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 in healthy volunteers through single ascending dose administered by either intravenous (IV) or subcutaneous (SC).
- Part 2 will evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of PRA-216 in healthy volunteers with repeat doses of multiple ascending dose administered subcutaneously.
Phase 2a of this study is a randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and immunogenicity of PRA-216 in participants with mild to moderate asthma. The dose of PRA-216 for this phase was determined from Phase 1.
Detailed description
This study is a Phase 1/2a randomized, double-blind, placebo-controlled, single- and multiple-dose study with staggered dose escalations in healthy participants and participants with mild to moderate asthma. Single-ascending dose (SAD) cohorts will be evaluated for one single dose administered. Multiple ascending dose (MAD) cohorts will be evaluated for repeat doses .
Participants with mild to moderate asthma will be recruited for Phase 2a of this study, to evaluate safety of randomized, double blind, placebo controlled PRA-216. The dose of PRA-216 for this phase was determined from Phase 1 safety, tolerability, and PK data. Additional dose levels or schedules may be used for Phase 2a, depending on data from Phase 1.
This study consists of 2 phases, as follows:
Phase 1, Part 1:
SAD in healthy volunteers. Study visits in this section will entail a single dose administration of PRA-216 or placebo and collection of study data.
Phase 1, Part 2:
MAD in healthy volunteers. Study visits in this section will entail repeat doses of PRA-216 or placebo and collection of study data.
Phase 2a Participants with mild to moderate asthma will receive PRA-216 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Phase 1, Part 1: SAD Cohorts: Active Drug | Experimental | Drug: PRA-216Healthy volunteers will receive a single dose of PRA-216 in a dose escalation format. |
| Phase 1, Part 1: SAD Cohorts: Placebo | Placebo comparator | Drug: PlaceboHealthy volunteers will receive a single dose of placebo |
| Phase 1, Part 2: MAD Cohort: Active Drug | Experimental | Drug: PRA-216Healthy volunteers will receive repeated doses of PRA-216 in a dose escalation format. |
| Phase 1, Part 2 MAD Cohort: Placebo Comparator | Placebo comparator | Drug: PlaceboHealthy volunteers will receive repeated doses of placebo comparator. |
| Phase 2a: Participants with mild to moderate asthma-active drug | Experimental | Drug: PRA-216Participants with mild to moderate asthma will be randomized to receive repeat doses of PRA-216. |
| Phase 2a: Participants with mild to moderate asthma-placebo | Placebo comparator | Drug: PlaceboParticipants with mild to moderate asthma will be randomized to receive repeat doses of placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-65
- Must be in good health with no significant medical history
- Willing and able to attend all study visits, comply with study requirements
- Able and willing to provide written informed consent
- Age 18-65
Key exclusion criteria (13 listed)
- Evidence of clinically significant condition or disease
- Any physical or psychological condition that prohibits study completion
- Known history of illicit drug use or drug abuse, harmful alcohol use (at the Investigator's discretion), alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study agent
- History of severe allergic reactions or hypersensitivity
- Donation or loss of ≥ 1 unit of whole blood or plasma within 2 months prior to dosing
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 |
|---|---|---|
| PRA-216biologic | Drug | Phase 1, Part 1: SAD Cohorts: Active Drug, Phase 1, Part 2: MAD Cohort: Active Drug, Phase 2a: Participants with mild to moderate asthma-active drug |
| Placebomatching placebo for PRA-216 | Drug | Phase 1, Part 1: SAD Cohorts: Placebo, Phase 1, Part 2 MAD Cohort: Placebo Comparator, Phase 2a: Participants with mild to moderate asthma-placebo |
Primary outcome
Phase 1: Incidence, nature, and severity of serious adverse events (SAEs) with a single dose of PRA-216 in healthy volunteers (SAD arm)
Time frame: Up to Study Day 169
Incidence, nature, and severity of serious adverse events (SAEs)
Phase 1: Incidence, nature, and severity of serious adverse events (SAEs) of multiple doses of PRA-216 in healthy volunteers (MAD arm)
Time frame: up to Study Day 169
Incidence, nature, and severity of and serious adverse events (SAEs)
Phase 2a: To evaluate the effect of multiple doses of PRA-216 compared to placebo on exhaled nitric oxide (FeNO) in asthma participants
Time frame: Up to Study Day 57
Fractional exhaled nitric oxide (FeNO) is a non-invasive biomarker of airway inflammation in asthma.
9 secondary outcomes
Phase 1: Immunogenicity of PRA-216: ADA in healthy volunteers
Time frame: Up to Study Day 169
Phase 1: Pharmacokinetics of PRA-216: Tmax in healthy volunteers
Time frame: Up to Study Day 169
Phase 1: Pharmacokinetics of PRA-216: AUC in healthy volunteers
Time frame: Up to Study Day 169
Phase 1: Pharmacokinetics of PRA-216: Cmax in healthy volunteers
Time frame: Up to Study Day 169
Phase 2a: Incidence, nature, and severity of serious adverse events (SAEs) of PRA-216 in patients with asthma
Time frame: Up to Study Day 197
Phase 2a: Immunogenicity of PRA-216: ADA in patients with asthma
Time frame: Up to Study Day 197
Phase 2a: Pharmacokinetics of PRA-216: Tmax in patients with asthma
Time frame: Up to Study Day 197
Phase 2a: Pharmacokinetics of PRA-216: AUC in patients with asthma
Time frame: Up to Study Day 197
Phase 2a: Pharmacokinetics of PRA-216: Cmax in patients with asthma
Time frame: Up to Study Day 197
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 6 Aug 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.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PRA-216 in people with Mild to Moderate Asthma, run by Prana Therapies Inc at 8 sites in 2 countries.
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 11 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia, New Zealand. 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 Linear site contact (+61 (0)8 6382 5110, enquiries@linear.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Incidence, nature, and severity of serious adverse events (SAEs) with a single dose of PRA-216 in healthy volunteers (SAD arm) (time frame: Up to Study Day 169). The study lists 3 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 6 Aug 2026.