Diabetes Mellitus, Type 1Phase 1NCT06685185
A Research Study of a New Medicine NNC0363-1063 in Healthy Participants and Participants With Type 1 Diabetes
A Phase 1 study testing NNC0363-1063, Insulin degludec and Insulin detemir in people with Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This study will look into testing a new medicine called NNC0363-1063 which may be used to treat people with diabetes. The study consists of three parts: Part 1 is a single ascending dose (SAD) study that comprises two subtypes: Part 1A conducted in healthy participants and Part 1B conducted in participants with type 1… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- NNC0363-1063, Insulin degludec and Insulin detemir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteGermany
- Study dates
- 12 Nov 2024to 18 Mar 2026
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Part 1A SAD (healthy participants)
- Male or female of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- Body mass index between 18.5-29.9 kilogram per square metre( kg/m^2) (both inclusive) at the day of screening.
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
- Part 1B SAD, Part 2 PoP and Part 3 Meal test (participants with T1D)
Show all 11Show fewer
- Male or female of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- Body mass index between 18.5-29.9 kg/m^2 (both inclusive) at the day of screening.
- Diagnosed with type 1 diabetes mellitus greater than or equal to( ≥)1 year prior to the day of screening.
- Considered to be generally healthy (except for mild conditions under stable treatment associated with type 1 diabetes mellitus) based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Who cannot join
- Part 1A SAD (healthy participants)
- Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method.
- Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Part 1B SAD, Part 2 PoP and Part 3 Meal test (participants with T1D)
- Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method.
- Any condition, except for mild conditions under stable treatment associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study Investigating Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of NNC0363-1063 in Healthy Participants and Participants With Type 1 Diabetes
This study will look into testing a new medicine called NNC0363-1063 which may be used to treat people with diabetes. The study consists of three parts: Part 1 is a single ascending dose (SAD) study that comprises two subtypes: Part 1A conducted in healthy participants and Part 1B conducted in participants with type 1 diabetes (T1D). This study part will last for about 1½ to 5½ weeks. Part 2 is a proof-of-principle (PoP) study part conducted in participants with T1D and will last for about 3½ to 8½ weeks. Part 3 is a meal test multiple dose study part conducted in participants with T1D and will last for 7 to 11 weeks.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- NNC0363-1063, Placebo, Insulin degludec, Insulin detemir
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0363-1063Drug
NNC0363-1063 will be administered subcutaneously.
PlaceboDrug
Placebo will be administered subcutaneously.
Insulin degludecDrug
Also called Tresiba
Insulin degludec will be administered subcutaneously.
Insulin detemirDrug
Also called Levemir
Insulin detemir will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Part 1A: SAD: NNC0363-1063 | Experimental | Participants will receive single dose of NNC0363-1063 subcutaneously. Receives: Drug: NNC0363-1063 |
| Part 1A: SAD: Placebo | Placebo comparator | Participants will receive NNC0363-1063 matching placebo subcutaneously. Receives: Drug: Placebo |
| Part 1B: SAD: NNC0363-1063 | Experimental | Participants will receive NNC0363-1063 subcutaneously. Receives: Drug: NNC0363-1063 |
| Part 1B: SAD: Insulin degludec | Active comparator | Participants will receive insulin degludec subcutaneously. Receives: Drug: Insulin degludec |
| Part 2: PoP: NNC0363-1063 | Experimental | Participants will receive NNC0363-1063 subcutaneously. Receives: Drug: NNC0363-1063 |
| Part 3 Meal test: NNC0363-1063 | Experimental | Participants will receive NNC0363-1063 subcutaneously. Receives: Drug: NNC0363-1063 |
| Part 3 Meal test: Insulin detemir | Active comparator | Participants will receive insulin detemir subcutaneously. Receives: Drug: Insulin detemir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 SAD: Number of adverse events
Measured in number of events.
Measured: From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)
Part 2 PoP: CL/F,I1063,SD- Apparent serum clearance of NNC0363-1063 after a single dose
Measured in millilitre per hour*kilogram (mL/[h*kg]).
Measured: From IMP administration at day 1 up to 7 days
Part 3 Meal test: AUC,PG,meal: Area under the plasma glucose concentration-time curve at steady state
Measured in hours*millimoles per litre (h*mmol/L).
Measured: At day 2 of visit 2 and visit 3 after initiation of meal test
Secondary outcomes (19)
Part 1 SAD: Number of hypoglycaemic episodes
Measured in number of episodes.
Measured: From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)
Part 1 SAD: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose
Measured in hours*picomoles per litre (h*pmol/L).
Measured: Up to 7 days
Part 1 SAD: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose
Measured in h*pmol/L.
Measured: Up to 2 days
Part 1 SAD: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose
Measured in picomoles per litre (pmol/L).
Measured: Up to 7 days
Part 2 PoP: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose
Measured in h*pmol/L.
Measured: Up to 7 days
Part 2 PoP: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose
Measured in h*pmol/L.
Measured: Up to 2 days
Part 2 PoP: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose
Measured in pmol/L.
Measured: Up to 7 days
Part 3 Meal test: AUC0-1h,PG,meal: Area under the plasma glucose concentration-time curve from 0 to 1 hour after initiation of the meal test at steady state
Measured in h*mmol/L.
Measured: From 0 hours to 1 hour after initiation of the meal test (day 2 of visit 2 and visit 3)
Part 3 Meal test: AUC0-2h,PG,meal: Area under the plasma glucose concentration-time curve from 0 to 2 hours after initiation of the meal test at steady state
Measured in h*mmol/L.
Measured: From 0 hours to 2 hours after initiation of the meal test (day 2 of visit 2 and visit 3)
Part 3 Meal test: AUC0-4h,PG,mean: Area under the plasma glucose concentration-time curve from 0 to 4 hours after initiation of the meal test at steady state
Measured in h*mmol/L.
Measured: From 0 hours to 4 hours after initiation of the meal test (day 2 of visit 2 and visit 3)
Part 3 Meal test: AUC0-6h,PG,meal: Area under the plasma glucose concentration-time curve from 0 to 6 hours after initiation of the meal test at steady state
Measured in h*mmol/L.
Measured: From 0 hours to 6 hours after initiation of the meal test (day 2 of visit 2 and visit 3)
Part 3 Meal test: PGmax,meal: Maximum observed plasma glucose concentration at steady state
Measured in millimoles per litre (mmol/L).
Measured: At day 2 of visit 2 and visit 3 after initiation of meal test
Part 3 Meal test: tPGmax,meal: Time to maximum observed plasma glucose concentration from at steady state
Measured in hours.
Measured: At day 2 of visit 2 and visit 3 after initiation of meal test
Part 3 Meal test: ΔPGav,0-1h,meal: Mean change in plasma glucose from 0 to 1 hour after initiation of the meal test at steady state
Measured in mmol/L.
Measured: From 0 hours to 1 hour after initiation of the meal test (day 2 of visit 2 and visit 3)
Part 3 Meal test: ΔPGav,0-2h,meal: Mean change in plasma glucose from 0 to 2 hours after initiation of the meal test at steady state
Measured in mmol/L.
Measured: From 0 hours to 2 hours after initiation of the meal test (day 2 of visit 2 and visit 3)
Part 3 Meal test: AUCτ,I1063,SS: Area under the serum NNC0363-1063 concentration-time curve during one dosing interval at steady state
Measured in h*pmol/L.
Measured: At day 2 of visit 2 and visit 3 after last IMP administration
Part 3 Meal test: Cmax,I1063,SS: Maximum observed serum NNC0363-1063 concentration during one dosing interval at steady state
Measured in pmol/L.
Measured: At day 2 of visit 2 and visit 3 after last IMP administration
Part 3 Meal test: Number of adverse events
Measured in number of events.
Measured: From first IMP administration (day 1 of visit 2 and visit 3) until 24 hours after last IMP administration (day 2 of visit 2 and visit 3)
Part 3 Meal test: Number of hypoglycaemic episodes
Measured in number of episodes.
Measured: From first IMP administration (day 1 of visit 2 and visit 3) until 24 hours after last IMP administration (day 2 of visit 2 and visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start12 Nov 2024
- Primary completion8 Mar 2026
- Study completion18 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685185
- Sponsor's protocol ID
- NN1644-7794
- Other IDs
- 2024-511808-17, U1111-1304-2544
- Status last verified
- Apr 2026
- First submitted
- 9 Nov 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Investigating Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of NNC0363-1063 in Healthy Participants and Participants With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06685185
- Acronym / sponsor ID
- NN1644-7794
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 8 Mar 2026 (actual)
- Study completion
- 18 Mar 2026 (actual)
- First posted
- 12 Nov 2024 (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 study will look into testing a new medicine called NNC0363-1063 which may be used to treat people with diabetes. The study consists of three parts: Part 1 is a single ascending dose (SAD) study that comprises two subtypes: Part 1A conducted in healthy participants and Part 1B conducted in participants with type 1 diabetes (T1D). This study part will last for about 1½ to 5½ weeks. Part 2 is a proof-of-principle (PoP) study part conducted in participants with T1D and will last for about 3½ to 8½ weeks. Part 3 is a meal test multiple dose study part conducted in participants with T1D and will last for 7 to 11 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part 1A: SAD: NNC0363-1063 | Experimental | Drug: NNC0363-1063Participants will receive single dose of NNC0363-1063 subcutaneously. |
| Part 1A: SAD: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive NNC0363-1063 matching placebo subcutaneously. |
| Part 1B: SAD: NNC0363-1063 | Experimental | Drug: NNC0363-1063Participants will receive NNC0363-1063 subcutaneously. |
| Part 1B: SAD: Insulin degludec | Active comparator | Drug: Insulin degludecParticipants will receive insulin degludec subcutaneously. |
| Part 2: PoP: NNC0363-1063 | Experimental | Drug: NNC0363-1063Participants will receive NNC0363-1063 subcutaneously. |
| Part 3 Meal test: NNC0363-1063 | Experimental | Drug: NNC0363-1063Participants will receive NNC0363-1063 subcutaneously. |
| Part 3 Meal test: Insulin detemir | Active comparator | Drug: Insulin detemirParticipants will receive insulin detemir subcutaneously. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Part 1A SAD (healthy participants)
- Male or female of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- Body mass index between 18.5-29.9 kilogram per square metre( kg/m^2) (both inclusive) at the day of screening.
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Key exclusion criteria (6 listed)
- Part 1A SAD (healthy participants)
- Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method.
- Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Part 1B SAD, Part 2 PoP and Part 3 Meal test (participants with T1D)
- Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method.
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 |
|---|---|---|
| NNC0363-1063NNC0363-1063 will be administered subcutaneously. | Drug | Part 1A: SAD: NNC0363-1063, Part 1B: SAD: NNC0363-1063, Part 2: PoP: NNC0363-1063, Part 3 Meal test: NNC0363-1063 |
| PlaceboPlacebo will be administered subcutaneously. | Drug | Part 1A: SAD: Placebo |
| Insulin degludecAlso: TresibaInsulin degludec will be administered subcutaneously. | Drug | Part 1B: SAD: Insulin degludec |
| Insulin detemirAlso: LevemirInsulin detemir will be administered subcutaneously. | Drug | Part 3 Meal test: Insulin detemir |
Primary outcome
Part 1 SAD: Number of adverse events
Time frame: From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)
Measured in number of events.
Part 2 PoP: CL/F,I1063,SD- Apparent serum clearance of NNC0363-1063 after a single dose
Time frame: From IMP administration at day 1 up to 7 days
Measured in millilitre per hour*kilogram (mL/[h*kg]).
Part 3 Meal test: AUC,PG,meal: Area under the plasma glucose concentration-time curve at steady state
Time frame: At day 2 of visit 2 and visit 3 after initiation of meal test
Measured in hours*millimoles per litre (h*mmol/L).
19 secondary outcomes
Part 1 SAD: Number of hypoglycaemic episodes
Time frame: From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)
Part 1 SAD: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose
Time frame: Up to 7 days
Part 1 SAD: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose
Time frame: Up to 2 days
Part 1 SAD: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose
Time frame: Up to 7 days
Part 2 PoP: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose
Time frame: Up to 7 days
Part 2 PoP: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose
Time frame: Up to 2 days
Part 2 PoP: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose
Time frame: Up to 7 days
Part 3 Meal test: AUC0-1h,PG,meal: Area under the plasma glucose concentration-time curve from 0 to 1 hour after initiation of the meal test at steady state
Time frame: From 0 hours to 1 hour after initiation of the meal test (day 2 of visit 2 and visit 3)
Part 3 Meal test: AUC0-2h,PG,meal: Area under the plasma glucose concentration-time curve from 0 to 2 hours after initiation of the meal test at steady state
Time frame: From 0 hours to 2 hours after initiation of the meal test (day 2 of visit 2 and visit 3)
Part 3 Meal test: AUC0-4h,PG,mean: Area under the plasma glucose concentration-time curve from 0 to 4 hours after initiation of the meal test at steady state
Time frame: From 0 hours to 4 hours after initiation of the meal test (day 2 of visit 2 and visit 3)
Part 3 Meal test: AUC0-6h,PG,meal: Area under the plasma glucose concentration-time curve from 0 to 6 hours after initiation of the meal test at steady state
Time frame: From 0 hours to 6 hours after initiation of the meal test (day 2 of visit 2 and visit 3)
Part 3 Meal test: PGmax,meal: Maximum observed plasma glucose concentration at steady state
Time frame: At day 2 of visit 2 and visit 3 after initiation of meal test
Part 3 Meal test: tPGmax,meal: Time to maximum observed plasma glucose concentration from at steady state
Time frame: At day 2 of visit 2 and visit 3 after initiation of meal test
Part 3 Meal test: ΔPGav,0-1h,meal: Mean change in plasma glucose from 0 to 1 hour after initiation of the meal test at steady state
Time frame: From 0 hours to 1 hour after initiation of the meal test (day 2 of visit 2 and visit 3)
Part 3 Meal test: ΔPGav,0-2h,meal: Mean change in plasma glucose from 0 to 2 hours after initiation of the meal test at steady state
Time frame: From 0 hours to 2 hours after initiation of the meal test (day 2 of visit 2 and visit 3)
Part 3 Meal test: AUCτ,I1063,SS: Area under the serum NNC0363-1063 concentration-time curve during one dosing interval at steady state
Time frame: At day 2 of visit 2 and visit 3 after last IMP administration
Part 3 Meal test: Cmax,I1063,SS: Maximum observed serum NNC0363-1063 concentration during one dosing interval at steady state
Time frame: At day 2 of visit 2 and visit 3 after last IMP administration
Part 3 Meal test: Number of adverse events
Time frame: From first IMP administration (day 1 of visit 2 and visit 3) until 24 hours after last IMP administration (day 2 of visit 2 and visit 3)
Part 3 Meal test: Number of hypoglycaemic episodes
Time frame: From first IMP administration (day 1 of visit 2 and visit 3) until 24 hours after last IMP administration (day 2 of visit 2 and visit 3)
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 9 Apr 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Related trials for Diabetes Mellitus, Type 1
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
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 NNC0363-1063, Insulin degludec and Insulin detemir in people with Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Germany.
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 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: finished, as of the sponsor's last update on 9 Apr 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 Germany. 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?
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?
Part 1 SAD: Number of adverse events (time frame: From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)). 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 9 Apr 2026.