Healthy VolunteersPhase 1NCT04196179

ANG-3070 in Healthy Adult Participants

A Phase 1 study testing ANG3070 in people with Healthy Volunteers, run by Angion Biomedica Corp at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a Phase 1 study, to assess the safety, tolerability, pharmacokinetics, and food effect of single and multiple ascending doses of ANG-3070 in healthy adult participants. This study is comprised of 12 cohorts. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: ANG3070
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 97 participants
Where: 1 siteAustralia
Study dates: 17 Dec 2019to 10 Mar 2021
Phase: Phase 1
Are there results?: None posted in the registry

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

Healthy male or female volunteers, aged 18 to 65 years (inclusive at the time of informed consent);
Participants must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening and/or before administration of the initial dose of study drug; and
Participants must have a minimum body weight of 50 kg and a Body Mass Index (BMI) between ≥18.0 and ≤32.0 kg/m2 at Screening;

Who cannot join

Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period;
Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, could adversely affect the safety of the participant;
History of gastrointestinal (GI) disorders such as celiac disease, atrophic gastritis, lactose intolerance, and Helicobacter (H.) pylori infection;
Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol;
Any surgical or medical condition that could interfere with the absorption, distribution, metabolism, or excretion of the study drug;

Trial locations and contacts

1 site in 1 country.

Australia1 site

Nucleus Network, VIC
Melbourne, 3004

Other trials in Australia

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Food Effect of ANG-3070 in Healthy Adult Participants

This is a Phase 1 study, to assess the safety, tolerability, pharmacokinetics, and food effect of single and multiple ascending doses of ANG-3070 in healthy adult participants.

This study is comprised of 12 cohorts. 5 single ascending dose (SAD) cohorts 6multiple ascending dose (MAD) cohorts, and 1 single dose food effect (FE) cross-over cohort Each cohort will have a total of 8 subjects: SAD and MAD (2 subjects receiving placebo and 6 subjects receiving active ANG-3070)

Read the detailed description

This is a Phase 1 study, to assess the safety, tolerability, pharmacokinetics, and food effect of single and multiple ascending doses of ANG-3070 in healthy adult participants.

Each cohort will have a total of 8 subjects: SAD and MAD (2 subjects receiving placebo and 6 subjects receiving active ANG-3070). The study design employs sentinel dosing with 2 subjects (1 placebo, 1 active treatment) at least 24 hours prior to remainder of cohort for dose cohort 1.

SAD cohorts are defined as follows, with the FE crossover occurring for participants in cohort A3 on Day 15 and in cohort D1 on Day 5:

A1 ANG-3070 50 mg (n=6) / Placebo (n=2) A2 ANG-3070 100 mg (n=6) / Placebo (n=2) A3 ANG-3070 200 mg (n=6) / Placebo (n=2) A3 Day 15ANG-3070 200mg (n=6) / Placebo (n=2) A4 ANG-3070 400 mg (n=6) / Placebo (n=2) A5 Day 1 ANG-3070 600 mg (n=6) / Placebo (n=2) D1 Day 1 ANG-3070 600 mg Single Dose (n=6) / Placebo (n=2) D1 Day 5 (ANG-3070 600 mg Single Dose (n=6) / Placebo (n=2)

MAD cohorts will receive drug or placebo twice daily for 14 consecutive days (Day 1 to Day 14) or drug or placebo once daily for 14 consecutive days (Day 1 to Day 14) as follows:

B1 ANG-3070 50 mg BID (n=6) / Placebo (n=2) B2 ANG-3070 100 mg BID (n=6) / Placebo (n=2) B3 ANG-3070 250 mg BID (n=6) / Placebo (n=2) B4 ANG-3070 500 mg BID (n=6) / Placebo (n=2) C1 ANG-3070 400 mg QD (n=6) / Placebo (n=2) C2 ANG-3070 600 mg QD (n=6) / Placebo (n=2)

Conditions: Healthy Volunteers
Being tested: ANG3070, Placebo oral capsule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ANG3070Drug
ANG-3070 drug product is a an immediate release oral solid. The drug product consists of a Size 00 Swedish orange capsule containing drug substance (10 mg, 50 mg, or 250 mg) with no excipients.
Placebo oral capsuleDrug
ANG-3070 placebo capsules visually match the drug product.

Study groups in NCT04196179
Study group	Role	What they receive
SAD	Experimental	A1 Day 1 ANG-3070 50 mg (n=6) / Placebo (n=2) Oral A2 Day 1 ANG-3070 100 mg (n=6) / Placebo (n=2) Oral A3 Day 1 ANG-3070 200 mg (n=6) / Placebo (n=2) Oral Day 15 ANG-3070 200mg (n=6) / Placebo (n=2) Oral A4 Day 1 ANG-3070 400 mg (n=6) / Placebo (n=2) Oral A5 Day 1 ANG-3070 600 mg (n=6) / Placebo (n=2) Oral D1 Single Dose Food Effect: Day 1 ANG 3070 600 mg with and without food (n=6)/ Placebo (n=2) Oral Receives: Drug: ANG3070; Drug: Placebo oral capsule
MAD	Experimental	B1 ANG-3070 50 mg BID (n=6) / Placebo (n=2) B2 ANG-3070 100 mg BID (n=6) / Placebo (n=2) B3 ANG-3070 250 mg BID (n=6) / Placebo (n=2) B4 ANG-3070 500 mg, BID (n=6)/ Placebo (n=2) C1 ANG-3070 400 mg, QD(n=6)/ Placebo (n=2) C2 ANG-3070 600 mg, QD (n=6)/ Placebo (n=2) Receives: Drug: ANG3070; Drug: Placebo oral capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in Adverse Events
Difference versus placebo in the number of subjects with adverse events to evaluate safety and tolerability of ANG3070.
Measured: Up to the Follow Up visit 8 days after the last study drug administration
Difference in Vital Signs
Difference versus placebo in the number of subjects with abnormal vital signs to evaluate safety and tolerability of ANG3070.
Measured: Up to the Follow Up visit 8 days after the last study drug administration
Difference in Physical Exam
Difference versus placebo in the number of subjects with abnormal Physical examination to evaluate safety and tolerability of ANG3070
Measured: Up to the Follow Up visit 8 days after the last study drug administration
Difference in Lab Values
Difference versus placebo in the number of subjects with abnormal lab values to evaluate safety and tolerability of ANG3070.
Measured: Up to the Follow Up visit 8 days after the last study drug administration
Difference in ECG QT interval
Difference versus placebo in the number of subjects with abnormal ECG QT interval to evaluate safety and tolerability of ANG3070
Measured: Up to the Follow Up visit 8 days after the last study drug administration

Secondary outcomes (1)

Assess PK
To assess the pharmacokinetics (PK) of single and multiple ascending doses of ANG-3070 and to evaluate the effect of a high fat meal on the PK of a single dose of ANG-3070 administered to healthy adult participants
Measured: Up to the Follow Up visit 8 days after the last study drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Dec 201910 Mar 2021

First posted12 Dec 2019
Study start17 Dec 2019
Primary completion27 Nov 2020
Study completion10 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies 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: 97 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04196179
Sponsor's protocol ID: ANG-3070-001
Status last verified: Jul 2021
First submitted: 9 Dec 2019
Last updated: 21 Jul 2021
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-Blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Food Effect of ANG-3070 in Healthy Adult Participants
ClinicalTrials.gov ID: NCT04196179
Acronym / sponsor ID: ANG-3070-001
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 97 participants (actual)
Lead sponsor: Angion Biomedica CorpIndustry (pharma, biotech, devices)
Study start: 17 Dec 2019 (actual)
Primary completion: 27 Nov 2020 (actual)
Study completion: 10 Mar 2021 (actual)
First posted: 12 Dec 2019 (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 Phase 1 study, to assess the safety, tolerability, pharmacokinetics, and food effect of single and multiple ascending doses of ANG-3070 in healthy adult participants.

Detailed description

This is a Phase 1 study, to assess the safety, tolerability, pharmacokinetics, and food effect of single and multiple ascending doses of ANG-3070 in healthy adult participants.

SAD cohorts are defined as follows, with the FE crossover occurring for participants in cohort A3 on Day 15 and in cohort D1 on Day 5:

MAD cohorts will receive drug or placebo twice daily for 14 consecutive days (Day 1 to Day 14) or drug or placebo once daily for 14 consecutive days (Day 1 to Day 14) as follows:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
SAD	Experimental	Drug: ANG3070, Drug: Placebo oral capsuleA1 Day 1 ANG-3070 50 mg (n=6) / Placebo (n=2) Oral A2 Day 1 ANG-3070 100 mg (n=6) / Placebo (n=2) Oral A3 Day 1 ANG-3070 200 mg (n=6) / Placebo (n=2) Oral Day 15 ANG-3070 200mg (n=6) / Placebo (n=2) Oral A4 Day 1 ANG-3070 400 mg (n=6) / Placebo (n=2) Oral A5 Day 1 ANG-3070 600 mg (n=6) / Placebo (n=2) Oral D1 Single Dose Food Effect: Day 1 ANG 3070 600 mg with and without food (n=6)/ Placebo (n=2) Oral
MAD	Experimental	Drug: ANG3070, Drug: Placebo oral capsuleB1 ANG-3070 50 mg BID (n=6) / Placebo (n=2) B2 ANG-3070 100 mg BID (n=6) / Placebo (n=2) B3 ANG-3070 250 mg BID (n=6) / Placebo (n=2) B4 ANG-3070 500 mg, BID (n=6)/ Placebo (n=2) C1 ANG-3070 400 mg, QD(n=6)/ Placebo (n=2) C2 ANG-3070 600 mg, QD (n=6)/ Placebo (n=2)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Healthy male or female volunteers, aged 18 to 65 years (inclusive at the time of informed consent);
Participants must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening and/or before administration of the initial dose of study drug; and
Participants must have a minimum body weight of 50 kg and a Body Mass Index (BMI) between ≥18.0 and ≤32.0 kg/m2 at Screening;

Key exclusion criteria (5 listed)

Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period;
Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, could adversely affect the safety of the participant;
History of gastrointestinal (GI) disorders such as celiac disease, atrophic gastritis, lactose intolerance, and Helicobacter (H.) pylori infection;
Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol;
Any surgical or medical condition that could interfere with the absorption, distribution, metabolism, or excretion of the study drug;

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
ANG3070ANG-3070 drug product is a an immediate release oral solid. The drug product consists of a Size 00 Swedish orange capsule containing drug substance (10 mg, 50 mg, or 250 mg) with no excipients.	Drug	MAD, SAD
Placebo oral capsuleANG-3070 placebo capsules visually match the drug product.	Drug	MAD, SAD

Primary outcome

Difference in Adverse Events
Time frame: Up to the Follow Up visit 8 days after the last study drug administration
Difference versus placebo in the number of subjects with adverse events to evaluate safety and tolerability of ANG3070.
Difference in Vital Signs
Time frame: Up to the Follow Up visit 8 days after the last study drug administration
Difference versus placebo in the number of subjects with abnormal vital signs to evaluate safety and tolerability of ANG3070.
Difference in Physical Exam
Time frame: Up to the Follow Up visit 8 days after the last study drug administration
Difference versus placebo in the number of subjects with abnormal Physical examination to evaluate safety and tolerability of ANG3070
Difference in Lab Values
Time frame: Up to the Follow Up visit 8 days after the last study drug administration
Difference versus placebo in the number of subjects with abnormal lab values to evaluate safety and tolerability of ANG3070.
Difference in ECG QT interval
Time frame: Up to the Follow Up visit 8 days after the last study drug administration
Difference versus placebo in the number of subjects with abnormal ECG QT interval to evaluate safety and tolerability of ANG3070

1 secondary outcome

Assess PK
Time frame: Up to the Follow Up visit 8 days after the last study drug administration

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
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. This study is not recruiting at the moment.

Shakil Aslam, MD study director

Angion Biomedica

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 ANG3070 in people with Healthy Volunteers, run by Angion Biomedica Corp 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 21 Jul 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Difference in Adverse Events (time frame: Up to the Follow Up visit 8 days after the last study drug administration). 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 NCT04196179.

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 21 Jul 2021.