AsthmaPhase 1NCT06920901
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Immunogenicity of APG777 in Adults With Asthma
A Phase 1 study testing APG777 in people with Asthma, run by Apogee Therapeutics, Inc. at 11 sites in 2 countries.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and immunogenicity of APG777 in adult participants with mild-to-moderate asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- APG777
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 27 Mar 2025to Mar 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of mild-to-moderate asthma (Global Initiative for Asthma 2023 criteria) ≥ 1 year prior to Screening
- Maintain FeNO-high (≥ 25 parts per billion [ppb]) or FeNO-low (< 25 ppb) status from Screening to Day 1 prior to Randomization
- Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 60% of predicted normal value at Screening
- Asthma Control Test (ACT) score > 19 at Screening
- Maintained control on as-needed short-acting beta-agonist (SABA) +/- stable dose inhaled corticosteroids (ICS) or stable dose of ICS/ long-acting beta-agonist (LABA); +/- stable dose leukotriene receptor antagonist (LTRA). ICS dose should be stable for ≥ 12 weeks prior to Day 1, LTRA dose should be stable for ≥ 8 weeks prior to Day 1
- Women of childbearing potential and male participants to use a highly effective form of contraception
Who cannot join
- Any asthma exacerbation requiring systemic corticosteroids within 12 weeks of Screening and/or any asthma exacerbation that resulted in overnight hospitalization within 6 months prior to Screening
- Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia
- History of biologics use for treatment or control of asthma
- Current smokers or participants with a smoking history of ≥ 10 pack years
- Known history of illicit drug abuse, harmful alcohol use
- Note: Other protocol defined criteria may apply.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States9 sites
Investigational Site
Edmond, Oklahoma, 73034
Investigational Site
Kansas City, Missouri, 66160
Investigational Site
La Jolla, California, 92037
Investigational Site
Long Beach, California, 90808
Investigational Site
Normal, Illinois, 61761
Investigational Site
Philadelphia, Pennsylvania, 19140
Investigational Site
Pittsburgh, Pennsylvania, 15241
Investigational Site
San Jose, California, 95117
Investigational Site
Torrance, California, 90505
United Kingdom2 sites
Investigational Site
Bradford, West Yorkshire, BD9 6RJ
Investigational Site
Manchester, M23 9QZ
About this study
Official title: A Phase 1b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of APG777 in Adults With Mild-to-Moderate Asthma
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and immunogenicity of APG777 in adult participants with mild-to-moderate asthma.
The duration of the study will be approximately 52 weeks (364 days) for each participant and will consist of a Screening Period, Treatment Period, and Follow-up Period.
- Conditions
- Asthma
- Being tested
- APG777, Placebo
- Keywords
- Asthma, Mild to moderate asthma, Tolerability, Immunogenicity, Pharmacokinetics
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APG777Drug
APG777 subcutaneous injection
PlaceboDrug
Matching placebo subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| APG777 | Experimental | Participants will receive protocol specified dose of APG7777 Receives: Drug: APG777 |
| Placebo | Placebo comparator | Participants will receive matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 52 weeks
Number of Participants with Abnormal Laboratory Findings
Measured: Up to 52 weeks
Number of Participants with Abnormal Vital Signs
Measured: Up to 52 weeks
Number of Participants with Abnormal Electrocardiograms (ECGs)
Measured: Up to 52 weeks
Number of Participants with Abnormal Physical Examination Findings
Measured: Up to 52 weeks
Secondary outcomes (12)
Maximum concentration (Cmax) of APG777
Measured: Up to 48 weeks
Time to reach Cmax (tmax)
Measured: Up to 48 weeks
Terminal elimination rate constant (λz)
Measured: Up to 48 weeks
Terminal Elimination half-life (t1/2)
Measured: Up to 48 weeks
Area Under the Serum Concentration-time curve (AUC) from Time 0 to the Last Quantifiable Time Point (AUC0-last)
Measured: Up to 48 weeks
AUC From Time 0 Extrapolated to Infinity (AUC0-inf)
Measured: Up to 48 weeks
Apparent Clearance of APG777 (CL/F)
Measured: Up to 48 weeks
Apparent Volume of Distribution (Vz/F)
Measured: Up to 48 weeks
Number of Participants with Anti-Drug-Antibodies (ADAs)
Measured: Up to 48 weeks
Cmax in Participants With and without ADAs
Measured: Up to 48 weeks
AUClast Participants With and without ADAs
Measured: Up to 48 weeks
AUCInf Participants With and without ADAs
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start27 Mar 2025
- Primary completion17 Sep 2026
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apogee Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920901
- Sponsor's protocol ID
- APG777-105
- Status last verified
- Oct 2026
- First submitted
- 27 Mar 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Lim XQ, Winter E, Nograles K, Xu J, Zhang ZQ, Thankamony S, Dillinger L, Dambkowski CL. A First-in-Human, Single- and Multiple-Dose Study of APG777, a Half-Life-Extended Anti-IL-13 Monoclonal Antibody, in Healthy Volunteers. Clin Transl Sci. 2025 Dec;18(12):e70456. doi: 10.1111/cts.70456.
PubMed 41422501
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
- A Phase 1b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of APG777 in Adults With Mild-to-Moderate Asthma
- ClinicalTrials.gov ID
- NCT06920901
- Acronym / sponsor ID
- APG777-105
- Conditions
- Asthma
- Keywords
- Asthma, Mild to moderate asthma, Tolerability, Immunogenicity, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Apogee Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 17 Sep 2026 (actual)
- Study completion
- Mar 2027 (estimated)
- First posted
- 10 Apr 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.
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and immunogenicity of APG777 in adult participants with mild-to-moderate asthma.
The duration of the study will be approximately 52 weeks (364 days) for each participant and will consist of a Screening Period, Treatment Period, and Follow-up Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APG777 | Experimental | Drug: APG777Participants will receive protocol specified dose of APG7777 |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have a diagnosis of mild-to-moderate asthma (Global Initiative for Asthma 2023 criteria) ≥ 1 year prior to Screening
- Maintain FeNO-high (≥ 25 parts per billion [ppb]) or FeNO-low (< 25 ppb) status from Screening to Day 1 prior to Randomization
- Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 60% of predicted normal value at Screening
- Asthma Control Test (ACT) score > 19 at Screening
- Maintained control on as-needed short-acting beta-agonist (SABA) +/- stable dose inhaled corticosteroids (ICS) or stable dose of ICS/ long-acting beta-agonist (LABA); +/- stable dose leukotriene receptor antagonist (LTRA). ICS dose should be stable for ≥ 12 weeks prior to Day 1, LTRA dose should be stable for ≥ 8 weeks prior to Day 1
Key exclusion criteria (6 listed)
- Any asthma exacerbation requiring systemic corticosteroids within 12 weeks of Screening and/or any asthma exacerbation that resulted in overnight hospitalization within 6 months prior to Screening
- Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia
- History of biologics use for treatment or control of asthma
- Current smokers or participants with a smoking history of ≥ 10 pack years
- Known history of illicit drug abuse, harmful alcohol use
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 |
|---|---|---|
| APG777APG777 subcutaneous injection | Drug | APG777 |
| PlaceboMatching placebo subcutaneous injection | Drug | Placebo |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 52 weeks
Number of Participants with Abnormal Laboratory Findings
Time frame: Up to 52 weeks
Number of Participants with Abnormal Vital Signs
Time frame: Up to 52 weeks
Number of Participants with Abnormal Electrocardiograms (ECGs)
Time frame: Up to 52 weeks
Number of Participants with Abnormal Physical Examination Findings
Time frame: Up to 52 weeks
12 secondary outcomes
Maximum concentration (Cmax) of APG777
Time frame: Up to 48 weeks
Time to reach Cmax (tmax)
Time frame: Up to 48 weeks
Terminal elimination rate constant (λz)
Time frame: Up to 48 weeks
Terminal Elimination half-life (t1/2)
Time frame: Up to 48 weeks
Area Under the Serum Concentration-time curve (AUC) from Time 0 to the Last Quantifiable Time Point (AUC0-last)
Time frame: Up to 48 weeks
AUC From Time 0 Extrapolated to Infinity (AUC0-inf)
Time frame: Up to 48 weeks
Apparent Clearance of APG777 (CL/F)
Time frame: Up to 48 weeks
Apparent Volume of Distribution (Vz/F)
Time frame: Up to 48 weeks
Number of Participants with Anti-Drug-Antibodies (ADAs)
Time frame: Up to 48 weeks
Cmax in Participants With and without ADAs
Time frame: Up to 48 weeks
AUClast Participants With and without ADAs
Time frame: Up to 48 weeks
AUCInf Participants With and without ADAs
Time frame: Up to 48 weeks
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.
- Derived from this study: PubMed 41422501Lim XQ, Winter E, Nograles K, Xu J, Zhang ZQ, Thankamony S, Dillinger L, Dambkowski CL. A First-in-Human, Single- and Multiple-Dose Study of APG777, a Half-Life-Extended Anti-IL-13 Monoclonal Antibody, in Healthy Volunteers. Clin Transl Sci. 2025 Dec;18(12):e70456. doi: 10.1111/cts.70456.
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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. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APG777 in people with Asthma, run by Apogee Therapeutics, Inc. at 11 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 6 inclusion and 6 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: under way, not looking for participants, 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 11 sites in United States, United Kingdom. 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 52 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06920901, which also lists 1 linked publication.
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.