SafetyPhase 1NCT03067363
First in Human Single Ascending Dose Study of MOR107
A Phase 1 study testing MOR107 and Low sodium diet in people with Safety, run by Alan Richardson at 1 site in United Kingdom.
Trial summary
This is the first in human study of MOR107. It is a 2 part, single centre, double-blind, randomised, placebo-controlled study in healthy male subjects. Part 1 is a single ascending dose study, and Part 2 is a parallel group, dose range finding study in healthy male subjects on a low sodium diet. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Safety
- What is being tested?
- MOR107 and Low sodium diet
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Feb 2017to 23 Mar 2017
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
- Age 18 to 45 years of age
- Body mass index of 18.0 to 32.0 kg/m2
- For Part 2, subjects must have at least a 25% reduction in 24 hour urinary sodium excretion on Day -2 compared with admission
Who cannot join
- Subjects who have received any IMP in a clinical research study within the previous three months
- Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening/admission
- Current smokers of e-cigarettes and nicotine replacement products and those who have smoked these products within the last 12 months
- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
- Positive drugs of abuse test result
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- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- History of psychiatric disorder, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Clinical
Nottingham, Nottinghamshire, NG11 6JS
About this study
Official title: Assessment of Safety, Tolerability and Pharmacokinetics of Single Ascending Subcutaneous Doses of MOR107 in Healthy Male Subjects and Pharmacodynamics in Healthy Male Subjects on a Low Sodium Diet
This is the first in human study of MOR107. It is a 2 part, single centre, double-blind, randomised, placebo-controlled study in healthy male subjects. Part 1 is a single ascending dose study, and Part 2 is a parallel group, dose range finding study in healthy male subjects on a low sodium diet.
Read the detailed description
MOR107 is an angiotensin 2 receptor (AT2R) agonist with the potential to treat a wide range of diseases through activation of the protective arm of the renin-angiotensin system.
In this study MOR107 will be administered to humans for the first time.
The study will enroll healthy male subjects and is split into two sequential parts, both of which have a single centre, double-blind, randomised, placebo-controlled design.
Part 1 will evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending doses of MOR107.
Part 2 will evaluate the pharmacodynamics, safety, tolerability and PK of three different doses of MOR107 in healthy male subjects who will be fed a low sodium diet in order to increase AT2R expression.
- Conditions
- Safety
- Being tested
- MOR107, Placebo, Low sodium diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOR107Drug
Also called LP2-3
MOR107 solution for injection
PlaceboDrug
Also called Placebo (for MOR107)
Solution for injection manufactured to match MOR107 solution for injection
Low sodium dietOther
Diet designed to restrict sodium intake to 40 mmol/day
| Study group | Role | What they receive |
|---|---|---|
| Part 1, MOR107 Dose level 1 | Experimental | MOR107, single subcutaneous injection Receives: Drug: MOR107 |
| Part 1, MOR107 Dose level 2 | Experimental | MOR107, single subcutaneous injection Receives: Drug: MOR107 |
| Part 1, MOR107 Dose level 3 | Experimental | MOR107, single subcutaneous injection Receives: Drug: MOR107 |
| Part 1, MOR107 Dose level 4 | Experimental | MOR107, single subcutaneous injection Receives: Drug: MOR107 |
| Part 1, MOR107 Dose level 5 | Experimental | MOR107, single subcutaneous injection Receives: Drug: MOR107 |
| Part 1, MOR107 Dose level 6 | Experimental | MOR107, single subcutaneous injection Receives: Drug: MOR107 |
| Part 1, Placebo | Placebo comparator | Placebo, single subcutaneous injection Receives: Drug: Placebo |
| Part 2: MOR107 low dose | Experimental | MOR107 low dose single subcutaneous injection and low sodium diet for 6 days before dosing and 2 days after dosing Receives: Drug: MOR107; Other: Low sodium diet |
| Part 2: MOR107 medium dose | Experimental | MOR107 medium dose single subcutaneous injection and low sodium diet for 6 days before dosing and 2 days after dosing Receives: Drug: MOR107; Other: Low sodium diet |
| Part 2: MOR107 high dose | Experimental | MOR107 high dose single subcutaneous injection and low sodium diet for 6 days before dosing and 2 days after dosing Receives: Drug: MOR107; Other: Low sodium diet |
| Part 2: Placebo | Placebo comparator | Placebo single subcutaneous injection and low sodium diet for 6 days before dosing and 2 days after dosing Receives: Drug: Placebo; Other: Low sodium diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (safety and tolerability)
Reporting of adverse events, physical examination, injection site assessment, vital signs, ECG, and clinical chemistry, haematology and urinalysis
Measured: Up to 10 days post-dose
Secondary outcomes (17)
Time from dosing at which the maximum MOR107 concentration was observed (Tmax)
Plasma PK parameter
Measured: Up to 48 hours post-dose
Maximum observed MOR107 concentration (Cmax)
Plasma PK parameter
Measured: Up to 48 hours post-dose
Concentration of MOR107 at 12 hours post-dose (C12)
Plasma PK parameter
Measured: 12 hours post-dose
Concentration of MOR107 at 24 hours post-dose (C24)
Plasma PK parameter
Measured: 24 hours post-dose
Area under the curve from 0 time to last measurable MOR107 concentration (AUC0-t)
Plasma PK parameter
Measured: Up to 48 hours post-dose
Area under the curve from 0 time to infinity for MOR107 (AUC0-inf)
Plasma PK parameter
Measured: Up to 48 hours post-dose
Percentage of AUC(0-inf) for MOR107 extrapolated beyond last measured time point (AUC%extrap)
Plasma PK parameter
Measured: Up to 48 hours post-dose
Slope of the apparent elimination phase for MOR107 (Lambda-z)
Plasma PK parameter
Measured: Up to 48 hours post-dose
Apparent elimination half-life for MOR107 (T-half)
Plasma PK parameter
Measured: Up 48 hours post-dose
MOR107 Cmax normalised for dose (Cmax/D)
Plasma PK parameter
Measured: Up to 48 hours post-dose
MOR107 AUC(0-t) normalised for dose (AUC[0-t]/D)
Plasma PK parameter
Measured: Up to 48 hours post-dose
MOR107 AUC(0-inf) normalised for dose (AUC[0-inf]/D)
Plasma PK parameter
Measured: Up to 48 hours post-dose
Amount of MOR107 excreted in the urine over a specified period of time after dosing (Ae)
Urine PK parameter
Measured: Up to 48 hours post-dose
Cumulative amount of MOR107 excreted in the urine (CumAe)
Urine PK parameter
Measured: Up to 48 hours post-dose
Amount of MOR107 excreted in the urine over a specified period of time after dosing, expressed as a percentage of the administered dose (Ae%)
Urine PK parameter
Measured: Up to 48 hours post-dose
Cumulative amount of MOR107 excreted in the urine, expressed as a percentage of the administered dose (CumAe%)
Urine PK parameter
Measured: Up to 48 hours post-dose
Renal clearance: the apparent volume of plasma cleared per unit time via renal elimination (CLr)
Urine PK parameter
Measured: Up to 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start16 Feb 2017
- Primary completion23 Mar 2017
- Study completion23 Mar 2017
Why it stopped: Part 1 completed successfully. Part 2 not conducted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part 1: single ascending doses Part 2: parallel group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alan Richardson
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Responsible party
- Sponsor-investigator, Alan Richardson, LanthioPep BV
- Investigators
- Axel Mescheder, MD, Study director, LanthioPep BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067363
- Sponsor's protocol ID
- MOR107-C001
- Status last verified
- Feb 2018
- First submitted
- 21 Feb 2017
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety, Tolerability and Pharmacokinetics of Single Ascending Subcutaneous Doses of MOR107 in Healthy Male Subjects and Pharmacodynamics in Healthy Male Subjects on a Low Sodium Diet
- ClinicalTrials.gov ID
- NCT03067363
- Acronym / sponsor ID
- MOR107-C001
- Conditions
- Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Part 1 completed successfully. Part 2 not conducted.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alan RichardsonIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 23 Mar 2017 (actual)
- Study completion
- 23 Mar 2017 (actual)
- First posted
- 1 Mar 2017 (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 the first in human study of MOR107. It is a 2 part, single centre, double-blind, randomised, placebo-controlled study in healthy male subjects. Part 1 is a single ascending dose study, and Part 2 is a parallel group, dose range finding study in healthy male subjects on a low sodium diet.
Detailed description
MOR107 is an angiotensin 2 receptor (AT2R) agonist with the potential to treat a wide range of diseases through activation of the protective arm of the renin-angiotensin system.
In this study MOR107 will be administered to humans for the first time.
The study will enroll healthy male subjects and is split into two sequential parts, both of which have a single centre, double-blind, randomised, placebo-controlled design.
Part 1 will evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending doses of MOR107.
Part 2 will evaluate the pharmacodynamics, safety, tolerability and PK of three different doses of MOR107 in healthy male subjects who will be fed a low sodium diet in order to increase AT2R expression.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
- Model description
- Part 1: single ascending doses Part 2: parallel group
| Arm | Type | Receives |
|---|---|---|
| Part 1, MOR107 Dose level 1 | Experimental | Drug: MOR107MOR107, single subcutaneous injection |
| Part 1, MOR107 Dose level 2 | Experimental | Drug: MOR107MOR107, single subcutaneous injection |
| Part 1, MOR107 Dose level 3 | Experimental | Drug: MOR107MOR107, single subcutaneous injection |
| Part 1, MOR107 Dose level 4 | Experimental | Drug: MOR107MOR107, single subcutaneous injection |
| Part 1, MOR107 Dose level 5 | Experimental | Drug: MOR107MOR107, single subcutaneous injection |
| Part 1, MOR107 Dose level 6 | Experimental | Drug: MOR107MOR107, single subcutaneous injection |
| Part 1, Placebo | Placebo comparator | Drug: PlaceboPlacebo, single subcutaneous injection |
| Part 2: MOR107 low dose | Experimental | Drug: MOR107, Other: Low sodium dietMOR107 low dose single subcutaneous injection and low sodium diet for 6 days before dosing and 2 days after dosing |
| Part 2: MOR107 medium dose | Experimental | Drug: MOR107, Other: Low sodium dietMOR107 medium dose single subcutaneous injection and low sodium diet for 6 days before dosing and 2 days after dosing |
| Part 2: MOR107 high dose | Experimental | Drug: MOR107, Other: Low sodium dietMOR107 high dose single subcutaneous injection and low sodium diet for 6 days before dosing and 2 days after dosing |
| Part 2: Placebo | Placebo comparator | Drug: Placebo, Other: Low sodium dietPlacebo single subcutaneous injection and low sodium diet for 6 days before dosing and 2 days after dosing |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males
- Age 18 to 45 years of age
- Body mass index of 18.0 to 32.0 kg/m2
- For Part 2, subjects must have at least a 25% reduction in 24 hour urinary sodium excretion on Day -2 compared with admission
Key exclusion criteria (9 listed)
- Subjects who have received any IMP in a clinical research study within the previous three months
- Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening/admission
- Current smokers of e-cigarettes and nicotine replacement products and those who have smoked these products within the last 12 months
- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
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 |
|---|---|---|
| MOR107Also: LP2-3MOR107 solution for injection | Drug | Part 1, MOR107 Dose level 1, Part 1, MOR107 Dose level 2, Part 1, MOR107 Dose level 3, Part 1, MOR107 Dose level 4, Part 1, MOR107 Dose level 5, Part 1, MOR107 Dose level 6, Part 2: MOR107 high dose, Part 2: MOR107 low dose, Part 2: MOR107 medium dose |
| PlaceboAlso: Placebo (for MOR107)Solution for injection manufactured to match MOR107 solution for injection | Drug | Part 1, Placebo, Part 2: Placebo |
| Low sodium dietDiet designed to restrict sodium intake to 40 mmol/day | Other | Part 2: MOR107 high dose, Part 2: MOR107 low dose, Part 2: MOR107 medium dose, Part 2: Placebo |
Primary outcome
Incidence of treatment-emergent adverse events (safety and tolerability)
Time frame: Up to 10 days post-dose
Reporting of adverse events, physical examination, injection site assessment, vital signs, ECG, and clinical chemistry, haematology and urinalysis
17 secondary outcomes
Time from dosing at which the maximum MOR107 concentration was observed (Tmax)
Time frame: Up to 48 hours post-dose
Maximum observed MOR107 concentration (Cmax)
Time frame: Up to 48 hours post-dose
Concentration of MOR107 at 12 hours post-dose (C12)
Time frame: 12 hours post-dose
Concentration of MOR107 at 24 hours post-dose (C24)
Time frame: 24 hours post-dose
Area under the curve from 0 time to last measurable MOR107 concentration (AUC0-t)
Time frame: Up to 48 hours post-dose
Area under the curve from 0 time to infinity for MOR107 (AUC0-inf)
Time frame: Up to 48 hours post-dose
Percentage of AUC(0-inf) for MOR107 extrapolated beyond last measured time point (AUC%extrap)
Time frame: Up to 48 hours post-dose
Slope of the apparent elimination phase for MOR107 (Lambda-z)
Time frame: Up to 48 hours post-dose
Apparent elimination half-life for MOR107 (T-half)
Time frame: Up 48 hours post-dose
MOR107 Cmax normalised for dose (Cmax/D)
Time frame: Up to 48 hours post-dose
MOR107 AUC(0-t) normalised for dose (AUC[0-t]/D)
Time frame: Up to 48 hours post-dose
MOR107 AUC(0-inf) normalised for dose (AUC[0-inf]/D)
Time frame: Up to 48 hours post-dose
Amount of MOR107 excreted in the urine over a specified period of time after dosing (Ae)
Time frame: Up to 48 hours post-dose
Cumulative amount of MOR107 excreted in the urine (CumAe)
Time frame: Up to 48 hours post-dose
Amount of MOR107 excreted in the urine over a specified period of time after dosing, expressed as a percentage of the administered dose (Ae%)
Time frame: Up to 48 hours post-dose
Cumulative amount of MOR107 excreted in the urine, expressed as a percentage of the administered dose (CumAe%)
Time frame: Up to 48 hours post-dose
Renal clearance: the apparent volume of plasma cleared per unit time via renal elimination (CLr)
Time frame: Up to 48 hours post-dose
Results and safety
The study was stopped early (reason given: Part 1 completed successfully. Part 2 not conducted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- 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. This study is not recruiting at the moment.
Axel Mescheder, MD study director
LanthioPep BV
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 MOR107 and Low sodium diet in people with Safety, run by Alan Richardson at 1 site in United Kingdom.
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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 7 Feb 2018. 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 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?
The study was stopped early (reason given: Part 1 completed successfully. Part 2 not conducted.). Results are not available in the source record.
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?
Incidence of treatment-emergent adverse events (safety and tolerability) (time frame: Up to 10 days post-dose). 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 7 Feb 2018.